Multi event Drug Recall Enforcement Report Class I voluntary initiated by Sun Pharmaceutical Industries, Inc., originally initiated on 01-03-2019 for the product 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] The product was recalled due to presence of particulate matter: foreign matter identified as glass detected in vecuronium bromide for injection.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0373-2019 | 01-03-2019 | 01-16-2019 | Class I | 1,384 cartons, 13,840 vials | 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] | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. | Terminated |
| D-0372-2019 | 01-03-2019 | 01-16-2019 | Class I | 12,534 cartons, 125,340 vials | 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] | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. | Terminated |
Recalled Products
