FDAClass IIJuly 6, 2022

Losartan potassium & Hydrochlorothiazide Tablets 100 recall: Impurity Out of Spec

Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx…

Why was Losartan potassium & Hydrochlorothiazide Tablets 100 recalled?

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

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 # BLM2114A, exp. date 07/2023

Product
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx…
Recalling firm
Macleods Pharma Usa Inc
Quantity
84/1000 count bottles
Distribution
Product was distributed nationwide.
Recall date
July 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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