Recalls / Class II
Class IID-1051-2019
Product
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.
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 530
- Distribution pattern
- California, Georgia, Indiana
Timeline
- Recall initiated
- 2019-03-06
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Terminated
- 2023-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1051-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.