FDAClass IIJuly 17, 2019

Losartan Potassium recall: Impurity Out of Spec

Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90

Why was Losartan Potassium recalled?

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: GS017651, Expiration 01/2020

Product
Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
Recalling firm
Golden State Medical Supply Inc.
Quantity
14,955 bottles (1,345,950 tablets)
Distribution
US Nationwide One (1) US government account. No foreign accounts.
Recall date
July 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls