Why it was recalled
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Product description
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
Lot numbers, UPCs & expiration codes
Count, lots, expiry: a) 30-count bottle C2218C, exp 9/2020, D1318E, exp 10/2020; b) 90-count bottle C2719J, exp 9/2020, E1818B, exp 10/2020.
Where it was sold
California, Georgia, Indiana
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-1051-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 530
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-1051-2019, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 82335
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Count, lots, expiry: a) 30-count bottle C2218C, exp 9/2020, D1318E, exp 10/2020; b) 90-count bottle C2719J, exp 9/2020, E1818B, exp 10/2020.
- Postal code
- 92807-1801
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1051-2019
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Product quantity
- 530
- Termination date
- Mar 30, 2023
- Reason for recall
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
- Distribution pattern
- California, Georgia, Indiana
- Recall initiation date
- Mar 6, 2019
- Initial firm notification
- Telephone
- Center classification date
- Mar 21, 2019