FDA Recall Terminated Historical recordClass II
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Published
- May 29, 2019
- Distribution
- IL, MI, MN, PA, TN, TX. Two (2) US gover…
