Four lots of the generic high blood pressure medication quinapril tablets have been recalled by its manufacturer, Lupin Pharmaceuticals, because of abnormally high amounts of a probable cancer-causing impurity.
This isn’t the first time high blood pressure medications have been recalled due to high amounts of nitrosamine. In April 2022, for example, Pfizer removed five lots of Accupril (quinapril HCl) tablets. In October, Aurobindo Pharma USA recalled two lots of quinapril-hydrochlorothiazide tablets.
Recent testing revealed levels of a nitrosamine impurity (N-nitroso-quinapril) were above the U.S. Food and Drug Administration’s (FDA) acceptable daily intake level.
Lupin is voluntarily recalling five (4) lots of Accupril (Quinapril HCl) tablets distributed by Lupin to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
What Are Nitrosamines?
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.
What Is Accupril(Quinapril)?
Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years.
Further Information
To date,Lupin is not aware of reports of adverse events that have been assessed to be related to this recall. Lupin believes the benefit/risk profile of the products remains positive based on currently available data.
Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.
Lots Recall Information
The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico.
- 20 mg tablets, lot number G102929, expiration date 04/2023
- 40 mg tablets, lot number G100533, expiration date 12/2022
- 40 mg tablets, lot number G100534, expiration date 12/2022
- 40 mg tablets, lot number G203071, expiration date 03/2024
Lupin places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Lupin has notified direct consignees by letter to arrange for return of any recalled product.
Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.
If you received a free product through the Lupin Patient Assistance Program (PAP) or the Lupin Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Inmar Rx.
Physician Information
Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Inmar Rx.
Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.
Lupin Contact Information
Anyone with questions regarding this latest recall should contact Inmar Rx Solutions at 877-538-8445, Monday to Friday, 9 a.m. to 5 p.m. EST. For reimbursement, consumers will need to provide the lot number, which can be found on the side of the bottle label.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
FDA Contact Informaton
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
References: https://www.fda.gov/drugs/drug safety and availability information about nitrosamine impurities and medications
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