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Just before Christmas, the FDA announced, as a public service, that drug manufacturer Lupin Pharmaceuticals Inc. has issued a voluntary recall for Quinapril — a blood pressure-lowering medication.
Some Quinapril tablets may contain levels of a nitrosamine impurity — N-Nitroso-Quinapril — that is above what is considered the acceptable daily limit.
Everyone is exposed to some level of nitrosamines. However, these impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
This is not the first time that a blood pressure drug has been recalled due to unacceptable levels of nitrosamines…
In March of 2022, Pfizer also performed a voluntary recall for similar medication.
Is your medication in the drug recall?
Lupin Pharmaceuticals Inc. is notifying pharmacies, drug chains and supermarkets to discontinue distribution of the affected drug.
Below are identifiers for the drug lots specifically affected by the drug recall:
Quinapril Tablets USP, 20 MG — Lot No G102929 — Expiration Date 04/2023
Quinapril Tablets USP, 40 MG —
Lot No G100533, Expiration Date 12/2022
Lot No G100534, Expiration Date 12/2022
Lot No G203071, Expiration Date 03/2024
For specifics on UPC codes, label images and more, visit the FDA, here.
What should you do?
The FDA advises that patients taking these medications should continue but contact their pharmacist, physician or another medical provider for advice on an alternative treatment.
The FDA also advised that 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.
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.