Drug product
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
D-0385-2021
Product summary
- Event
- Event 87833
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 147 bottles (14,700 extended release tablets)
- Official record key
drug-enforcement:D-0385-2021
Official wording
Reason: CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Code information: Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
Distribution pattern: Distributed to two physician consignees located in FL.
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity