FDAFDA · Alimentos y medicamentos·N.º oficial D-1349-2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10
Publicado el 1 de julio de 2020 · Inicio del retiro: 29 de mayo de 2020
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Qué hacer
Voluntary: Firm initiated · Press Release
Detalles del retiro
- Marca
- METFORMIN HYDROCHLORIDE
- Fabricante
- Amneal Pharmaceuticals of New York, LLC
- Distribuidor
- Nationwide
- UPC
- 0365162178104
- Lote
- AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273A 10/31/2021 AM191274A 10/31/2021 AM191338A 11/30/2021 AM191339A 11/30/2021 AM191340A 11/30/2021 AM191341 12/31/2021 AM191342 12/31/2021 AM200109 12/31/2021 AM200110 12/31/2021 AM200111 12/31/2021
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States
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