Class II
Terminated
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- April 30, 2019
- Posted
- May 22, 2019
- Recall Number
- D-1281-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Anaheim, CA, United States
Reason for Recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Distribution
CA, GA, IN. No DOD/VA accounts. No foreign accounts.
Lot / Code Info
a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020
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