Drug product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
D-1348-2020
Product summary
- Event
- Event 85781
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1348-2020
Official wording
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Code information: HF02318A 6/30/2020 HF02418A 6/30/2020 HF02518A 6/30/2020 HF07718A 6/30/2020 HH02118A 7/31/2020 HM04418A 12/31/2020 HM04518A 12/31/2020 HM04618A 12/31/2020 HM04718A 12/31/2020 HM05518A 12/31/2020 HM05618A 12/31/2020 HM05718A 12/31/2020 HM05818A 12/31/2020 HM05918A 12/31/2020 HM06018A 12/31/2020
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
NDMA) impurity
-
Manufacturing or process control
CGMP Deviations