RecallRadar

FDA Drug recall D-0759-2022

quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977…

On 2022-04-13 the FDA classified a Class II recall of quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977… by Pfizer, citing CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0759-2022
ClassificationClass II
Statusterminated
Initiated2022-03-21
Published2022-04-13
Last updated2026-09-13 11:52 UTC
CompanyPfizer
DistributionUS

Product

quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1

Reason

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

Identifiers

code_infoLots DN6931, ED3904 & ED3905; Exp. 03/2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0759-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.