Class II
Terminated
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.
This recall has been terminated (originally issued March 27, 2019).
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- March 6, 2019
- Posted
- March 27, 2019
- Recall Number
- D-1051-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 530
- Firm Location
- Anaheim, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Distribution
California, Georgia, Indiana
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.
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