FDAApril 3, 2020drug

Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.

What to do

FDA enforcement status: Terminated

Brands named

golden state medical supplygoldengolden state

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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