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QUINAPRIL HYDROCHLORIDE Recall D-0873-2022

Description: Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

QUINAPRIL HYDROCHLORIDE Recall D-0873-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0873-2022
Event ID90064
BrandACCUPRIL
Generic NameQUINAPRIL HYDROCHLORIDE
ManufacturerQUINAPRIL HYDROCHLORIDE
Original Package?1
Active SubstanceQUINAPRIL HYDROCHLORIDE
Drug RouteORAL
DistributionNationwide and Puerto Rico
Quantity10,304 bottles
Recall ReasonCGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Drug ClassificationClass II
Drug Code Info20220525
Product NDC0071-0527 0071-0530 0071-0532
Drug UPC0300710530232 0300710527232 0300710532236
Recall Initiation Date20220422
Report Date20220525
Classification Date20220516
Address235 East 42nd Street
New York, NY 10017-5703
United States
Recalling FirmPfizer Inc.
Initial Notification Press Release
Unique Ingredient Identifier33067B3N2M
Drug Application NumberNDA019885
Structured Product Labeling (SPL ID)cd5fc1c5-7459-494c-b1d9-0064b6a4891d
Structured Product Labeling (SPL Set ID)63cf5651-d52c-4d27-9fd4-ed9cd9724dff
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