Lupin Pharmaceuticals Inc. has issued a voluntary recall on four lots of blood pressure medicine due to its cancer risk, said the U.S. Food and Drug Administration.
According to the recall, the Quinapril Tablets were recalled 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.
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 and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below:
| Product | Lot No | Expiry | NDC | UPC | Distribution Dates |
|---|---|---|---|---|---|
| Quinapril Tablets USP, 20mg | G102929 | 04/2023 | 68180-558-09 (90’s) |
368180558095 | 03/15/2021 – 09/01/2022 |
| Quinapril Tablets USP, 40mg | G100533 G100534 G203071 |
12/2022 12/2022 03/2024 |
68180-554-09 (90’s) |
368180554097 |
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.
Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (877) 538-8445 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.
For more on the recall, click here
