Class II
Ongoing
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
This recall is currently active, issued May 8, 2019. It was issued by Legacy Pharmaceutical Packaging Llc.
- Recall Initiated
- April 24, 2019
- Posted
- May 8, 2019
- Recall Number
- D-1263-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60,012 bottles
- Firm Location
- Earth City, MO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Distribution
TN, AZ
Lot / Code Info
Lot 181598; 02/2021
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