Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical

FDA recall notice · announced January 16, 2019 · Sun Pharmaceutical Industries

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]

Reason for recall

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
Quantity: 12,534 cartons, 125,340 vials
Status: Terminated
Products in this recall event:
- Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 3 (D-0373-2019)
- Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 (D-0372-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.