Reported May 29, 2019 · Terminated
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Golden State Medical Supply Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Golden State Medical Supply Inc. · 5187 Camino Ruiz · Camarillo, CA · 93012-8601
Is this the product you have?
- Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
- Lot codes and dates
GS014045exp 06/2019GS014305 exp 06/2019GS014044 exp 0/2019GS016535 exp 01/2020GS016524 exp 01/2020GS017384 exp 02/2020GS017385 exp 01/2020GS017539 exp 01/2020GS017540 exp 01/2020GS017543 exp 01/2020GS017542 exp 01/2020 GS017984 exp 02/2020GS017985 exp 02/2020GS017986 exp 02/2020GS018263 exp 02/2020GS018264 exp 02/2020GS018265 exp 02/2020
- Amount recalled
- 138,213 HDPE Bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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