FDAClass IIApril 13, 2022

quinapril and hydrochlorothiazide tablets recall: Impurity Out of Spec

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

Why was quinapril and hydrochlorothiazide tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot FE3714; Exp. 02/2023

Product
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
Recalling firm
Pfizer Inc.
Quantity
2442 bottles
Distribution
Nationwide
Recall date
April 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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