Recalls / Class II
Class IID-319-2013
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.
- Affected lot / code info
- Lot # 130251, 130252, 130253 Exp date: 11/14
Why it was recalled
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.
Recalling firm
- Firm
- Legacy Pharmaceutical Packaging LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 13480 Lakefront Dr, Earth City, Missouri 63045-1516
Distribution
- Quantity
- 484,236 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-22
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2014-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-319-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.