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Recall Observatory FDA recall evidence

Drug 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

D-1238-2020

April 03, 2020

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 85401
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-1238-2020

Official wording

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

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

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Impurity for N-nitroso-N-methyl-4-aminobutryric Acid
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations