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HYDROCHLOROTHIAZIDE Recall D-0758-2022

Description: quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9

HYDROCHLOROTHIAZIDE Recall D-0758-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0758-2022
Event ID89864
BrandQUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Generic NameQUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ManufacturerQUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Original Package?1
Active SubstanceHYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE
Drug RouteORAL
DistributionNationwide
Quantity2442 bottles
Recall ReasonCGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Drug ClassificationClass II
Drug Code Info20220413
Product NDC59762-0220 59762-0222 59762-0223
Product NUIN0000175359 N0000175419 M0471776
Drug UPC0359762022219 0359762022011 0359762321299
Pharma Class (PE)Increased Diuresis [PE]
Pharma Class (EPC)Thiazide Diuretic [EPC]
Pharma Class (CS)Thiazides [CS]
Recall Initiation Date20220321
Report Date20220413
Classification Date20220406
Address235 East 42nd Street
New York, NY 10017-5703
United States
Recalling FirmPfizer Inc.
Initial Notification Press Release
Unique Ingredient Identifier33067B3N2M 0J48LPH2TH
Drug Application NumberNDA020125
Structured Product Labeling (SPL ID)46a33cf7-f5c5-4afb-b464-27a36773fe52
Structured Product Labeling (SPL Set ID)a4985462-793f-45ab-bbee-43bc9d1135ce
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