Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are six reported to the FDA since Aug. 24:
- Sun Pharmaceuticals recalls metformin after finding NDMA
Sun Pharmaceuticals has recalled one lot of its metformin pills after finding levels of N-Nitrosodimethylamine, or NDMA, a carcinogen, above the acceptable daily intake limit. - Acella recalls thyroid drug for subpotency
Acella Pharmaceuticals has recalled two lots of its thyroid drugs due to subpotency. - Becton Dickinson recalls Alaris infusion pump system for several hardware issues
Becton Dickinson has recalled its Alaris infusion pump system for a series of hardware issues that the FDA classified as Class I, the most serious type of recall, meaning use of the device could result in serious injury or death. - RLC labs recalls thyroid drug due to subpotency
RLC Labs, a drugmaker that focuses on drugs to treat hypothyroidism, recalled 483 lots of its Nature-Throid and WP Thyroid drugs after an FDA review found they were subpotent. - Mylan recalls 2 drugs after label mix-up
Mylan has recalled four lots of amiodarone HCl injection, which treats heart rhythm issues, and tranexamic acid injection, which promotes blood-clotting, after learning of a carton label mix-up. - Smiths Medical recalls syringe pumps due to risk of medication delivery error
Smiths Medical has recalled its Medfusion syringe pumps after finding a software issue may lead to over- or underdelivery of medication.