Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
Reported: May 29, 2019 Initiated: May 1, 2019 #D-1284-2019
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
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- 11,286 HDPE Bottles
- Distribution
- IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated. Recalled by Golden State Medical Supply Inc.. Units affected: 11,286 HDPE Bottles.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2019. Severity: Moderate. Recall number: D-1284-2019.
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