Product Safety Recalls

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LOSARTAN POTASSIUM Recall D-0838-2022

Description: Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

LOSARTAN POTASSIUM Recall D-0838-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0838-2022
Event ID89916
BrandLOSARTAN POTASSIUM
Generic NameLOSARTAN POTASSIUM
ManufacturerLOSARTAN POTASSIUM
Original Package?1
Active SubstanceLOSARTAN POTASSIUM
Drug RouteORAL
DistributionProduct was distributed nationwide
Quantity657,336 bottles
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220511
Product NDC68180-376 68180-210 68180-211
Drug UPC0368180211068 0368180212065 0368180210061
Recall Initiation Date20220331
Report Date20220511
Classification Date20220503
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient Identifier3ST302B24A
Drug Application NumberANDA078232
Structured Product Labeling (SPL ID)b20b3678-bd1a-4ca6-9f79-b4a27aa003bd
Structured Product Labeling (SPL Set ID)e5886220-43b7-46e1-9034-5242ba245bd1
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