FDA Drug · D-1164-2022

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 Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Class II · Terminated

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

Affected lots / codes — check yours against thisLot # BLM2114A, exp. date 07/2023

Recalling firm: Macleods Pharma Usa Inc, Plainsboro, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 84/1000 count bottles
Distribution: Product was distributed nationwide.
Recall initiated: June 10, 2022
Classified: June 27, 2022
Terminated: May 23, 2024
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1164-2022%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

See every recall for this brand: Is LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE recalled? →

Check this brand across all 8 databases →