The impurity is N-nitrosodiethylamine (NDEA), a naturally occurring substance in some foods, water, air pollution and industrial processes. NDEA is classified as a probable human carcinogen.
Patients on the drugs that have been recalled are being told to continue taking them because of the risk of stopping taking them. Patients are then being told to call a pharmacist or doctor for an alternative treatment before returning the medications.
The medication comes in bottles. Patients are being told to check the product name, manufacturer details and batch or lot number on the bottle and compare it to the list on the FDA's website.
For a complete list of the recalled medication, click here.
If you have medical questions about the recall, you can call Aurobindo Pharma USA, Inc at 1-866-850-2876, option 2 or email pvg@aurobindousa.com.
As for questions about returns, you’re being directed to call Inmar/CLS-Medturn at 1-877-208-2407 from 9 a.m. to 5 p.m. EST, or email rxrecalls@inmar.com.
Credit: DaytonDailyNews
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