Drug product
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59
D-1626-2020
Product summary
- Event
- Event 86471
- Status
- Terminated
- Classification
- Class III
- Quantity
- 111,948 bottles
- Official record key
drug-enforcement:D-1626-2020
Official wording
Reason: Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Code information: Lot #: 201626, Exp. Date 08/2022
Distribution pattern: Walmart distribution centers in GA and AR
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets