D-1285-2019 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
- 138,213 HDPE Bottles
Product Description
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 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
GS014045,exp 06/2019, GS014305 exp 06/2019, GS014044 exp 0/2019, GS016535 exp 01/2020, GS016524 exp 01/2020, GS017384 exp 02/2020, GS017385 exp 01/2020, GS017539 exp 01/2020, GS017540 exp 01/2020, GS017543 exp 01/2020, GS017542 exp 01/2020 GS017984 exp 02/2020, GS017985 exp 02/2020, GS017986 exp 02/2020, GS018263 exp 02/2020, GS018264 exp 02/2020, GS018265 exp 02/2020