Accupril Quinapril HCl Tablets Recalled for Elevated Nitrosamine Impurity
Pfizer is recalling Accupril (Quinapril HCl) 20 mg tablets nationwide and in Puerto Rico due to N-nitrosoquinapril levels exceeding acceptable limits. Affected lots include DX8682 and DG1188.
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: This is an FDA Class II recall of a prescription medication contaminated with N-nitrosoquinapril, a known carcinogenic impurity. No illnesses or injuries have been reported, which per the rubric places this in the 'high-risk products where injury has not yet been reported' category.
Plain-English summary
Pfizer is recalling Accupril (Quinapril HCl Tablets) 20 mg, 90-tablet bottles due to Current Good Manufacturing Practice (CGMP) deviations. The recalled product contains N-nitrosoquinapril above acceptable limits.
N-nitrosoquinapril is a potential carcinogenic impurity. The presence of this substance above acceptable levels represents a manufacturing deviation from required quality standards.
The recall affects 10,304 bottles distributed nationwide and in Puerto Rico. Affected lot numbers are DX8682 (expiring March 31, 2023) and DG1188 (expiring March 31, 2022).
Patients currently taking Accupril from the affected lots should contact their healthcare provider or pharmacist for guidance. Do not discontinue medication without consulting a healthcare professional, as the underlying condition being treated may require continued therapy.
The recalled product
- Product
- Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
- Manufacturer
- Pfizer Inc.
- Hazard
- nitrosamine
- manufacturing-defect
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)
- Lots: DX8682 Exp. MAR 31 2023
- DG1188 Exp. MAR 31 2022
Distribution
Distributed nationwide across the United States.
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