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HYDROCHLOROTHIAZIDE Recall D-0755-2022

Description: Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23

HYDROCHLOROTHIAZIDE Recall D-0755-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0755-2022
Event ID89864
BrandACCURETIC
Generic NameQUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ManufacturerQUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Original Package?1
Active SubstanceHYDROCHLOROTHIAZIDE QUINAPRIL HYDROCHLORIDE
Drug RouteORAL
DistributionNationwide
Quantity160 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 NDC0071-0220 0071-0222 0071-0223
Product NUIN0000175359 N0000175419 M0471776
Drug UPC0300717225230 0300715212232 0300710222236
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)1d3fab62-2114-4d5b-b07a-9b0f2b5a3efd
Structured Product Labeling (SPL Set ID)80e9d61d-9674-4ac4-b84c-79a875d408dd
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