Drug product
Metformin 750 mg Extended Release NDC # 70518-2920-00
D-0366-2022
Product summary
- Event
- Event 89331
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 Blister Cards
- Official record key
drug-enforcement:D-0366-2022
Official wording
Reason: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Code information: Lot # J0511265-021121, exp. date 02/28/2022 J0499451-122220, exp. date 01/31/2022 J0496563-120820, exp. date 12/31/2021 J0495111-120120, exp. date 12/31/2021
Distribution pattern: Product was distributed to one direct account in PA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations