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]
- Recall Initiated
- January 3, 2019
- Posted
- January 16, 2019
- Recall Number
- D-0373-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,384 cartons, 13,840 vials
- Firm Location
- Cranbury, NJ, United States
Reason for Recall
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: JKS0400A, EXP 03/2019
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