Product Safety Recalls

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LISINOPRIL Recall D-1536-2022

Description: Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03

LISINOPRIL Recall D-1536-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1536-2022
Event ID90859
BrandLISINOPRIL
Generic NameLISINOPRIL
ManufacturerLISINOPRIL
Original Package?1
Active SubstanceLISINOPRIL
Drug RouteORAL
DistributionProduct was distributed to major distributors/wholesalers nationwide.
Quantity11,802 1000-count bottles
Recall ReasonPresence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Drug ClassificationClass II
Drug Code Info20220921
Product NDC68180-512 68180-513 68180-517
Drug UPC0368180517306 0368180979012
Recall Initiation Date20220913
Report Date20220921
Classification Date20220915
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierE7199S1YWR
Drug Application NumberANDA077321
Structured Product Labeling (SPL ID)133b3fec-07f6-41f5-9c7c-50b66c4c0677
Structured Product Labeling (SPL Set ID)7d6c31e2-b5a4-4279-8013-a8dad37ea73b
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