OPHTHALMICA PTY LTD · 66-41 · SOUTH AFRICA
For OPHTHALMICA PTY LTD · 66-41 · SOUTH AFRICA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SOUTH AFRICA; product code is 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 68 - - - -- Animal Devices and Diagnostic Products | 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 08/02/2022; address is Park Bldg , 101 Albert Road , Centurion, Gauteng SOUTH AFRICA, verified against its source on 2026-09-16.
- Firm
- OPHTHALMICA PTY LTD verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- SOUTH AFRICA verified
- Address
- Park Bldg , 101 Albert Road , Centurion, Gauteng SOUTH AFRICA verified
- Date published
- 08/02/2022 verified
- Product code
- 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 68 - - - -- Animal Devices and Diagnostic Products | 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology each item verified
- FDA notes
- Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. | Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. each item verified
What the source says
OPHTHALMICA PTY LTD Date Published : 08/02/2022 Park Bldg , 101 Albert Road , Centurion, Gauteng SOUTH AFRICA 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 60 - - - -- Human and Animal Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 61 - - - -- Human and Animal Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 62 - - - -- Human and Animal Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 63 - - - -- Human and Animal Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 64 - - - -- Human and Animal Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 65 - - - -- Human and Animal Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 66 - - - -- Human and Animal Drugs Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 68 - - - -- Animal Devices and Diagnostic Products Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 73 - - - -- Anesthesiology Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 74 - - - -- Cardiovascular Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 76 - - - -- Dental Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 77 - - - -- Ear,Nose And Throat Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 78 - - - -- Gastroenterological & Urological Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 79 - - - -- General & Plastic Surgery Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 80 - - - -- General Hospital/Personal Use Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 84 - - - -- Neurological Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 85 - - - -- Obstetrical & Gynecological Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 86 - - - -- Ophthalmic Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 87 - - - -- Orthopedic Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 89 - - - -- Physical Medicine Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use. 90 - - - -- Radiology Date Published: 08/02/2022 Notes: Riboflavin Solution For Corneal Cross-Linking (CXL); Prior shipments have described the product as riboflavin, vitamin B2, isotonic / eye solution, or Peschke solution. For shipments intended for human use and declared as an IND, field staff should follow the CDER IND JOB AID. If the shipment meets the JOB AID criteria, the field should release. If not, the shipment is subject to DWPE under this listing and field staff should submit a CMS case to CDER for review. Shipments declared for tradeshow use or laboratory use should be DWPE under this listing and field staff should collect product labeling, an intended use letter, and verify quantity before submitting a CMS case to CDER for review. Field staff should consult IA 68-19 for all shipments intended for animal use.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.