United States
Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue. Lupin discontinued the marketing of Quinapril tablets in September 2022. It was distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets.
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. Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles. The recalled lots are included in the table below:
Product: Quinapril Tablets USP, 20mg
Lot No: G102929
Expiry: 04/2023
NDC: 68180-558-09 (90’s)
UPC: 368180558095
Distribution Dates: 03/15/2021 – 09/01/2022
Product: Quinapril Tablets USP, 40mg
Lot No: G100534, G203071, G100533
Expiry: 12/2022, 12/2022, 03/2024
NDC: 68180-554-09 (90’s)
UPC: 368180554097
Distribution Dates: 03/15/2021 – 09/01/2022
Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.
Patients taking, Quinapril Tablets USP, 20mg, and 40mg 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, 20mg, and 40mg that are being recalled should discontinue distribution of the recalled product lots immediately.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company name: Lupin Pharmaceuticals Inc.
Brand name: Lupin
Product recalled: Quinapril 20 and 40 mg tablets
Reason of the recall: Presence of nitrosamine impurity, N-Nitroso-Quinapril
FDA Recall date: December 21, 2022
Source:
www.fda.gov
