Quinapril Tablets Recalled Due to Excess Impurity Above Limits
Lupin Pharmaceuticals is recalling Quinapril tablets (20 mg) due to N-nitroso-quinapril impurity detected above acceptable daily intake limits. The recall affects approximately 23,736 units 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 N-nitroso-quinapril impurity exceeding acceptable daily intake limits. This qualifies as a risk-of-harm product due to the regulatory deviation, though no illnesses or injuries have been reported.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Quinapril tablets USP 20 mg due to a manufacturing deviation detected during quality control testing. Analysis identified N-nitroso-quinapril impurity in the product at levels exceeding the acceptable daily intake limit set by regulatory standards.
The affected product is Quinapril Tablets USP, 20 mg in 90-pack bottles, bearing Lot Number G102929 with an expiration date of April 2023. Approximately 23,736 units were distributed nationwide by major distribution chains. The product was manufactured by Lupin Limited in Goa, India, for Lupin Pharmaceuticals Inc. in Baltimore, Maryland.
Patients currently taking this medication should contact their healthcare provider or pharmacist before making any changes to their treatment. Consumers with questions about this recall may contact Lupin Pharmaceuticals or the FDA.
The recalled product
- Product
- QUINAPRIL (QUINAPRIL)
- Brand
- QUINAPRIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug
- Hazard
- n-nitroso-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 #: G102929
- Exp 04/2023
UPCs (2)
- 0368180559092
- 0368180556091
Distribution
Distributed nationwide across the United States.
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