FDAFDA · Food and drugs·Recall number D-0018-2021
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Published October 14, 2020 · Recall initiated: April 30, 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Direct Rx
- Distributor
- GA
- Lot
- Lot: 27AU1801 Exp. 02/28/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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