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
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- 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.
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