Class II
Terminated
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
- Recall Initiated
- March 1, 2019
- Posted
- April 10, 2019
- Recall Number
- D-1075-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 179,544 30-count bottles
- Firm Location
- Earth City, MO, United States
Reason for Recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Distribution
AZ, IN, TN
Lot / Code Info
Lots: 180190, 180191 (exp 10/2020) and 181597 (exp 02/2021)
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