Prescription Drug Quinapril Recalled for Chemical Impurity Exceeding Safety Limits
Lupin Pharmaceuticals is recalling Quinapril 40mg tablets due to detection of N-Nitroso-quinapril impurity above acceptable daily intake limits. The recall affects approximately 30,612 bottles 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: This FDA Class II recall involves a chemical impurity (N-Nitroso-quinapril) detected above acceptable daily intake limits with no reported illnesses or injuries, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Quinapril Tablets USP, 40 mg, a prescription medication distributed nationwide through major distribution chains. The recall covers lot numbers G100533, G100534 (expiration date 12/2022) and G203071 (expiration date 03/2024), totaling approximately 30,612 bottles.
The recall was issued due to detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Current Good Manufacturing Practice (CGMP) deviations during the manufacturing process resulted in the presence of this impurity in the recalled tablets.
Patients currently taking the recalled Quinapril should contact their healthcare provider or pharmacist for guidance. Do not stop taking your medication without medical advice. Return any remaining medication to a pharmacy for proper disposal.
The recalled product
- Product
- QUINAPRIL (QUINAPRIL)
- Brand
- QUINAPRIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Cardiovascular
- Hazard
- n-nitroso-impurity
- 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 (5)
- Lot #: G100533
- G100534
- Exp. 12/2022
- G203071
- Exp. 03/2024
UPCs (2)
- 0368180559092
- 0368180556091
Distribution
Distributed nationwide across the United States.
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