FDAFDA · Food and drugs·Recall number D-0032-2021
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Published October 7, 2020 · Recall initiated: March 12, 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 deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Direct Rx
- Distributor
- FL
- Lot
- Lot: 12DE1806 Exp. 01/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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