Pfizer Recalls Blood Pressure Tablets Due to Manufacturing Defects
Pfizer is recalling quinapril HCl/hydrochlorothiazide tablets due to manufacturing defects that allowed N-nitroso impurities to exceed acceptable daily intake limits. Patients taking affected lots should contact their pharmacy.
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 with CGMP deviations resulting in N-nitroso impurities exceeding FDA acceptable daily intake limits. No illnesses or injuries have been reported, placing this in the category of risk-of-harm product where injury has not yet been reported.
Plain-English summary
Pfizer Inc. is recalling quinapril HCl/hydrochlorothiazide 20 mg/12.5 mg tablets due to manufacturing defects. The affected lots are DN6931, ED3904, and ED3905, with an expiration date of March 2023. A total of 21,108 bottles were distributed nationwide.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations that resulted in N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurities in the tablets at levels exceeding the FDA's acceptable daily intake limits.
Patients taking tablets from the affected lots should consult with their healthcare provider or pharmacist regarding this recall. The medication was distributed by Greenstone, LLC and manufactured by Pfizer Inc.
The recalled product
- 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
- Manufacturer
- Pfizer Inc.
- Hazard
- manufacturing-defect
- chemical-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 (3)
- Lots DN6931
- ED3904 & ED3905
- Exp. 03/2023
Distribution
Distributed nationwide across the United States.
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