Class II
Terminated
Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
- Company
- Golden State Medical Supply Inc.
- Recall Initiated
- May 1, 2019
- Posted
- May 29, 2019
- Recall Number
- D-1282-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,668 HDPE bottles
- Firm Location
- Camarillo, CA, United States
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
IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Lot / Code Info
GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020
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