The Recall Desk
HighFDA (Drugs)·D-0760-2022·Announced 2022-04-13

Pfizer Recalls Quinapril/Hydrochlorothiazide Tablets for N-Nitroso Impurities

Pfizer is recalling 1,104 bottles of quinapril/hydrochlorothiazide tablets due to nitrosamine impurities above acceptable limits. The affected lot (DP3414) was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for nitrosamine impurities above acceptable daily intake limits, meeting the criterion of a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Pfizer Inc. is recalling 1,104 bottles of quinapril/hydrochlorothiazide 20 mg/25 mg tablets (Lot DP3414, expiration date 02/2023). The recall is due to manufacturing deviations that resulted in N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurities above the acceptable daily intake limit. The affected lot was distributed nationwide.

Quinapril/hydrochlorothiazide is a combination blood pressure medication. The FDA classified this as a Class II recall.

The recalled product

Product
quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
Manufacturer
Pfizer Inc.
Category
Drug
Hazard
  • nitrosamine-impurity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot DP3414
  • Exp 02/2023

Distribution

Distributed nationwide across the United States.

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