OLOWOLOMAKURE ENT. · 66-41 · NIGERIA
For OLOWOLOMAKURE ENT. · 66-41 · NIGERIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is NIGERIA; product is Senuebo | Senuebo | Senuebo | Senuebo | Senuebo; product code is 54 A - - -- Vitamin | 54 C - - -- Protein | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 61 - - - -- Human and Animal Drugs | 66 V - - -- Patent Medicines, Etc; date published is 03/06/2024; address is 145 Powerline Road , Ifo, Ogun NIGERIA, verified against its source on 2026-09-16.
- Firm
- OLOWOLOMAKURE ENT. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- NIGERIA verified
- Address
- 145 Powerline Road , Ifo, Ogun NIGERIA verified
- Date published
- 03/06/2024 verified
- Product code
- 54 A - - -- Vitamin | 54 C - - -- Protein | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 61 - - - -- Human and Animal Drugs | 66 V - - -- Patent Medicines, Etc each item verified
- Product
- Senuebo | Senuebo | Senuebo | Senuebo | Senuebo each item verified
- FDA notes
- Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. each item verified
What the source says
OLOWOLOMAKURE ENT. Date Published : 03/06/2024 145 Powerline Road , Ifo, Ogun NIGERIA 54 A - - -- Vitamin Date Published: 03/06/2024 Desc: Senuebo Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 54 C - - -- Protein Date Published: 03/06/2024 Desc: Senuebo Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 03/06/2024 Desc: Senuebo Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 61 - - - -- Human and Animal Drugs Date Published: 03/06/2024 Desc: Senuebo Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 66 V - - -- Patent Medicines, Etc Date Published: 03/06/2024 Desc: Senuebo Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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