FDA MedWatch – Four Lots of Quinapril Tablets by Lupin Pharmaceuticals

TOPIC: Four Lots of Quinapril Tablets by Lupin Pharmaceuticals: Recall – Due to Potential Presence of N-Nitroso-Quinapril Impurity

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Lupin Pharmaceuticals is recalling four lots, G102929, G100533, G100534, and G203071 of quinapril tablets due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake level.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Lupin discontinued the marketing of quinapril tablets in September 2022.

To date, Lupin has received no reports of illness that appear to relate to this issue.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: Quinapril is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. 

RECOMMENDATIONS: 

• Patients taking, quinapril tablets USP, 20 mg, and 40 mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

• Wholesalers, distributors and retailers that have quinapril tablets USP, 20 mg, and 40 mg that are being recalled should discontinue distribution of the recalled product lots immediately.

• Patients, wholesalers, distributors, and retailers with questions regarding this recall should contact the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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