The Recall Desk
SevereFDA (Drugs)·D-1238-2020·Announced 2020-04-22

Losartan Potassium Tablets Recalled Due to NBMA Impurity Detection

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because an impurity, NBMA, was detected in the active ingredient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant chemical impurities like NBMA in pharmaceutical products.

Plain-English summary

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets, USP, 25 mg, Rx only, in 30-count, 90-count, and 1,000-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving the detection of an impurity, N-nitroso-N-methyl-4-aminobutryric Acid (NBMA), in the active ingredient (API) used to manufacture the finished products.

The affected products were manufactured by Arrow Pharm (Malta) Ltd. and packaged by GSMS Incorporated in Camarillo, CA. The recall covers specific lot codes with expiration dates ranging from June 30, 2020, to July 31, 2020. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on alternative medications or replacements. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot Code: GS018406
  • Exp. Date 6/30/2020
  • GS018858
  • Exp. Date 7/31/2020
  • GS019108
  • GS018521
  • GS018605
  • GS018911

Distribution

Distributed nationwide across the United States.