Drug 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]
D-0372-2019
Product summary
- Event
- Event 81891
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12,534 cartons, 125,340 vials
- Official record key
drug-enforcement:D-0372-2019
Official wording
Reason: Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Code information: Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign matter