D-1282-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2019
- Initiation Date
- May 1, 2019
- Termination Date
- February 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,668 HDPE bottles
Product Description
Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
Reason for Recall
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
Distribution Pattern
IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Code Information
GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020