Why it was recalled
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Product description
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
Lot numbers, UPCs & expiration codes
Lot 181598; 02/2021
Where it was sold
TN, AZ
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-1263-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 24, 2019
- FDA report date
- May 8, 2019
- Quantity
- 60,012 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
Original FDA data
Every field from FDA enforcement report D-1263-2019, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 82710
- Address
- 13333 Lakefront Dr
- Code information
- Lot 181598; 02/2021
- Postal code
- 63045-1514
- Report date
- May 8, 2019
- Product type
- Drugs
- Recall number
- D-1263-2019
- Classification
- Class II
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- Product quantity
- 60,012 bottles
- Reason for recall
- CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
- Distribution pattern
- TN, AZ
- Recall initiation date
- Apr 24, 2019
- Initial firm notification
- Press Release
- Center classification date
- May 1, 2019