PlainRecalls
FDA Drug Critical Class I Terminated

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-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]

Reported: January 16, 2019 Initiated: January 3, 2019 #D-0373-2019

Product Description

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-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]

Reason for Recall

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

Details

Units Affected
1,384 cartons, 13,840 vials
Distribution
Nationwide in the USA
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
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-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 1,384 cartons, 13,840 vials.
Why was this product recalled?
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 16, 2019. Severity: Critical. Recall number: D-0373-2019.