8 recent drug, device recalls

Here are eight drug and medical device recalls the FDA reported in December:

1. Dewei Medical Equipment pulled 250,000 DNA/RNA preservation kits off the market in a class 1 recall — the most serious type — because the FDA did not approve them. There have been zero reports of injuries or complaints related to the recall. 

2. Remel recalled nearly 19,000 lab plates because of the risk of false results. There have been zero reported deaths and injuries related to the recall.

3. Teleflex and its subsidiary Arrow International recalled two types of catheter kits in a class 1 recall because of the risk of a cross-lumen leak, which can cause bleeding, fluid leakage, delayed treatment, serious injury or death. Zero injuries or deaths were reported alongside the recall of 1,355 devices. 

4. Arrow International recalled about 2,000 balloon pumps in a class 1 recall after receiving 135 complaints of the battery life fizzling out. No deaths or injuries were reported. 

5. Whele recalled 544,212 Mighty Bliss electric heating pads in a class 1 recall because of 31 reported injuries including electric shocks, burns, rashes or irritation. Between July 2021 and September 2022, there have been nearly 300 complaints and zero deaths reported. 

6. Lupin Pharmaceuticals recalled four lots of quinapril tablets because of the presence of nitrosamine, a carcinogen that has caused numerous drug recalls. There have been zero reports of illness related to the recall. 

7. Hospira recalled one lot of vancomycin hydrochloride injection because of the presence of visible glass particles in one vial. 

8. Accord Healthcare recalled one lot of daptomycin for injection 500 mg/vial and one lot of daptomycin for injection 350 mg/vial because a hospital pharmacy reported a labeling error. Zero deaths or injuries have been reported.

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