FDAFDA · Food and drugs·Recall number D-1075-2019
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
Published April 10, 2019 · Recall initiated: March 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Legacy Pharmaceutical Packaging LLC
- Distributor
- AZ, IN, TN
- Lot
- Lots: 180190, 180191 (exp 10/2020) and 181597 (exp 02/2021)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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