Drug 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]
D-0373-2019
Product summary
- Event
- Event 81891
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,384 cartons, 13,840 vials
- Official record key
drug-enforcement:D-0373-2019
Official wording
Reason: Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Code information: Lot #: JKS0400A, EXP 03/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign matter