D-1284-2019 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
- 11,286 HDPE Bottles
Product Description
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 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
GS015204 exp 06/ 2019, GS018318 exp 02/2020, GS014817 exp 06/2019, GS017342 exp 02/2020, GS017808 exp 02/2020