FDA-Drug2022-05-11Class II
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sold states
Product was distributed nationwide
Affected count
1,466,150 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2022Don't want to check this manually?
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