Four lots of Quinapril Tablets are being recalled by Lupin Pharmaceuticals Inc. due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, according to the FDA.
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Officials found the impurity in recent testing, which they say is above the acceptable daily intake level.
We’re told the impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time, but as of Dec. 21, Lupin has received no reports of illness that appear to relate to this issue.
The Quinapril tablet USP is a medicine used as a treatment of hypertension – to lower blood pressure, the FDA said.
The tablets, 20mg and 40mg, are packaged in 90-count bottles and were distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets, officials said.
You can find information on the recalled lots from the FDA 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 | 03/15/2021 – 09/01/2022 |
The FDA said if you’re taking tablets included in the recall, you’re advised to continue taking your medication and contact your pharmacist, physician, or medical provider for advice regarding alternative treatment.
If you have questions about the recall, you can contact Inmar Rx Solutions, Inc. at (877) 538-8445 Monday through Friday from 9:00 a.m. to 5:00 p.m. EST, the FDA said.
Additionally, officials said that adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting in any of the following ways:
- Regular mail or fax: Download the form here 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