Drug Enforcement D-319-2013

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.

Status

Terminated

Classification

Class II

Report Date

May 22, 2013

Termination Date

February 13, 2014

Product Information

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.
Product quantity
484,236 cartons
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.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Legacy Pharmaceutical Packaging LLC
Address
13480 Lakefront Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-319-2013
Event ID
64974
Recall initiation date
April 22, 2013
Center classification date
May 16, 2013
Code info
Lot # 130251, 130252, 130253 Exp date: 11/14
More code info