Recall: D-0843-2022

Class II - Potentially Harmful

Class IIClassification

2022-03-31Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA

Reason

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

Distribution

Product was distributed nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.