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Recall Observatory FDA recall evidence

Drug product

LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30

D-1357-2014

April 14, 2014

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 68009
Status
Terminated
Classification
Class II
Quantity
6,042 bottles
Official record key
drug-enforcement:D-1357-2014

Official wording

Reason: Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning

Code information: Lot Number GS003057. Exp Date 03/2016.

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance