Why it was recalled
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Product description
Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
Lot numbers, UPCs & expiration codes
Lots: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-20
Where it was sold
Wal-Mart distribution centers in AR, CA, GA, IN and MD
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-1048-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 1, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 456,732 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
Original FDA data
Every field from FDA enforcement report D-1048-2019, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 82326
- Address
- 13333 Lakefront Dr
- Code information
- Lots: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-20
- Postal code
- 63045-1514
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1048-2019
- Classification
- Class II
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- Product quantity
- 456,732 bottles
- Reason for recall
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
- Distribution pattern
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Recall initiation date
- Mar 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2019