7 recent drug, device recalls

Here are seven drug and medical device recalls the FDA reported in October: 

1. Golden State Medical Supply recalled one lot of its clopidogrel tablets and one lot of atenolol tablets because of a label mix-up. No adverse effects have been reported. 

2. LivaNova recalled 484 blood pumps in a class 1 recall, the most serious type. The company's LifeSPARC Controller could malfunction, triggering the device to enter critical failure mode. LivaNova reported 66 complaints, and the FDA has received two injury claims.

3. Jiangsu Well Biotech recalled 110,000 COVID-19 rapid tests because the FDA has not approved the product. The recall is labeled as class 1 because of the risk of a false positive or false negative. No complaints have been reported. 

4. Exela Pharma Sciences recalled 49 lots of its sodium bicarbonate injection product because of vial breakage, which has caused five reports of "flying glass injuring skin, eye and/or other parts," according to the FDA. 

5. Philips Respironics amended its recall of sleep apnea masks to include more than 18 million devices. It's a class 1 recall because the product's magnets can interfere with implanted metal medical devices — such as pacemakers — and "can potentially cause injury or death," according to the FDA. Philips has reported 43 complaints and 14 serious injuries. 

6. Mylan Institutional recalled one lot of its octreotide acetate injection product after receiving one complaint about glass particles being present in the syringe that packages the product. 

7. Aurobindo Pharma recalled two lots of quinapril and hydrochlorothiazide tablets because of the presence of nitrosamines, a drug substance impurity. No adverse effects have been reported.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars

>