quinapril HCl/hydrochlorothiazide tablets recall: Impurity Out of Spec
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
Why was quinapril HCl/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?
Lots DN6931, ED3904 & ED3905; Exp. 03/2023
- 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
- Recalling firm
- Pfizer Inc.
- Quantity
- 21108 bottles
- Distribution
- Nationwide
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)