Drug product
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
D-1364-2020
Product summary
- Event
- Event 85880
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bottles
- Official record key
drug-enforcement:D-1364-2020
Official wording
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Code information: J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020
Distribution pattern: Product was distributed to two medical clinics located in FL.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations