D-319-2013 Class II Terminated

Recalled by Legacy Pharmaceutical Packaging LLC — Earth City, MO

Recall Details

Product Type
Drugs
Report Date
May 22, 2013
Initiation Date
April 22, 2013
Termination Date
February 13, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
484,236 cartons

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

Lot # 130251, 130252, 130253 Exp date: 11/14