Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are six reported to the FDA since July 17:
- Bayshore Pharmaceuticals recalls metformin
Bayshore Pharmaceuticals has recalled one lot of its metformin tablets due to the detection of N-Nitrosodimethylamine, or NDMA, a carcinogen, above the acceptable daily intake limit. - SCA Pharmaceuticals recalls heparin sodium
SCA Pharmaceuticals has recalled 10 lots of heparin sodium that were found to contain benzyl alcohol, an undeclared preservative. Serious adverse effects are likely to occur in premature neonates and low-birth weight infants who receive benzyl alcohol. - BD recalls ChloraPrep device due to potential fungal contamination
Becton, Dickinson and Co. has recalled its ChloraPrep device due to possible fungal contamination. The company said the recall only applies to specific U.S. territories and other countries with high heat and humidity. - Ferring Pharmaceuticals recalls nasal spray due to superpotency
Ferring Pharmaceuticals has recalled all lots of its DDAVP Nasal Spray due to superpotency or amounts of desmopressin higher than specified, which could lead to seizure, coma and death. - Fresenius Kabi recalls sedative, cites possible cross-contamination
Fresenius Kabi has recalled two lots of the sedative dexmedetomidine due to the possibility of cross-contamination with lidocaine. - Verathon recalls laryngoscopy device
Verathon has recalled its GlideScope Core VIdeo Laryngoscopy System, a device used to provide a clear view of a patient's airway and vocal cords for medical procedures. The recall was initiated due to the potential for temporary or complete loss of image when used with Core 10 and Core 15 video monitors, which may cause serious adverse effects, including hypoxia and death.