Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are seven that have been reported to the FDA since Oct. 1:
- Lupin Pharmaceuticals recalled several batches of its irbesartan tablets after an analysis revealed that certain batches contained more of the carcinogen N-nitrosoirbesartan than is allowed by the FDA. Irbesartan is used to treat hypertension.
- Teligent Pharma recalled five lots of its lidocaine topical solution after testing found it was super potent, meaning it could result in a higher than intended lidocaine dose.
- DeRoyal Industries recalled 2,856 procedure packs that contain an irrigation warming set that may leak aluminum.
- Medtronic recalled the remote control of certain insulin pumps because it is vulnerable to hackers.
- Imperative Care recalled its Zoom 71 reperfusion catheter, used to remove blood clots in the brain after a stroke, because of an increased risk of the device breaking during use. There have been nine reports of serious injuries due to the issue, and no deaths reported.
- Coppertone recalled five types of its aerosol sunscreen after finding they contain benzene, a carcinogen.
- Bayer recalled all unexpired lots of its Lotrimin and Tinactin sprays, which are over-the-counter antifungal products, due to the presence of benzene, a carcinogen, in some samples of the products.