Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378
Recalled May 11, 2022 · FDA recall D-0840-2022 · Lupin Pharmaceuticals
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · FDA Class II
Units
1,247,067 bottles
Sold at
Product was distributed nationwide
Description
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →