D-1051-2019 Class II Terminated
FDA drug recall D-1051-2019 was initiated by Preferred Pharmaceuticals, Inc on March 6, 2019 and is designated Class II. Reason for recall: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. The recall status is terminated (terminated March 30, 2023). Affected quantity: 530.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- March 6, 2019
- Termination Date
- March 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 530
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.
Reason for Recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Distribution Pattern
California, Georgia, Indiana
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.