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.
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.
Lot numbers, UPCs & expiration codes
Lot # 130251, 130252, 130253 Exp date: 11/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-319-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2013
- FDA report date
- May 22, 2013
- Quantity
- 484,236 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
Original FDA data
Every field from FDA enforcement report D-319-2013, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 64974
- Address
- 13480 Lakefront Dr
- Code information
- Lot # 130251, 130252, 130253 Exp date: 11/14
- Postal code
- 63045-1516
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-319-2013
- Classification
- Class II
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- Product quantity
- 484,236 cartons
- Termination date
- Feb 13, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 22, 2013
- Initial firm notification
- Telephone
- Center classification date
- May 16, 2013