Reference Source

Caplin Steriles Limited · 66-41 · INDIA

For Caplin Steriles Limited, import alert is 66-41; country is INDIA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Amoxicilina 500 mg capsulas | Fluconazol Capsulas; product code is 56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced) | 61 W - - 45 Fluconazole (Anti-Fungal) (Not Antibiotic); date published is 06/30/2014; address is 895 - 897 Guruvarajakandigai , Survey No 895 - 897 , Gummidipoondi, Tamil Nadu INDIA, verified against its source on 2026-10-01.

Firm
Caplin Steriles Limited verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
INDIA verified
Address
895 - 897 Guruvarajakandigai , Survey No 895 - 897 , Gummidipoondi, Tamil Nadu INDIA verified
Date published
06/30/2014 verified
Product code
56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced) | 61 W - - 45 Fluconazole (Anti-Fungal) (Not Antibiotic) each item verified
Product
Amoxicilina 500 mg capsulas | Fluconazol Capsulas each item verified
FDA notes
OAISS declared Mfg is drogueria saimed; El Salvador. MFg. indicated on product label is drogueria saimed; El Salvador and Caplin Point Laboratories Ltd; India. | AMOXICILLIN; each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Caplin Steriles Limited Date Published : 06/30/2014 895 - 897 Guruvarajakandigai , Survey No 895 - 897 , Gummidipoondi, Tamil Nadu INDIA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

56 B - - 03 Amoxicillin Trihydrate (Penicillin, Synthetically Produced) Date Published: 03/25/2015 Desc: Amoxicilina 500 mg capsulas Notes: OAISS declared Mfg is drogueria saimed; El Salvador. MFg. indicated on product label is drogueria saimed; El Salvador and Caplin Point Laboratories Ltd; India. Problems: AMOXICILLIN; 61 W - - 45 Fluconazole (Anti-Fungal) (Not Antibiotic) Date Published: 06/30/2014 Desc: Fluconazol Capsulas

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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.