Sun Pharmaceutical Industries announced a voluntary recall of 3 lots of Vecuronium Bromide for Injection 10mg and 1 lot of Vecuronium Bromide for Injection 20mg after the product was found to contain glass.
Vecuronium Bromide, a neuromuscular blocker, is indicated as adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. If a drug containing glass particulate is administered intravenously, it may cause local irritation or swelling due to the foreign material. Serious events may include potentially life-threatening blockage and clotting in blood vessels.
The recalled lots are as follows:
- Vecuronium Bromide for Injection 20mg: Lot #JKS0400A, Exp 03/2019 (1384 cartons)
- Vecuronium Bromide for Injection 10mg: Lot #JKS0443A, Exp 03/2019 (4404 cartons)
- Vecuronium Bromide for Injection 10mg: Lot #JKS0444A, Exp 03/2019 (3744 cartons)
- Vecuronium Bromide for Injection 10mg: Lot #JKS0477A, Exp 03/2019 (4386 cartons)
The affected products were distributed nationally to wholesalers and medical facilities. At this time, the Company has not received reports of any adverse events related to this recall.
For more information call (800) 406-7984 or visit FDA.gov.