Drug product
Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO. NDC 68645-445-70.
D-319-2013
Product summary
- Event
- Event 64974
- Status
- Terminated
- Classification
- Class II
- Quantity
- 484,236 cartons
- Official record key
drug-enforcement:D-319-2013
Official wording
Reason: Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
Code information: Lot # 130251, 130252, 130253 Exp date: 11/14
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Error