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]
Reported: January 16, 2019 Initiated: January 3, 2019 #D-0372-2019
Product Description
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]
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
- 12,534 cartons, 125,340 vials
- Distribution
- Nationwide in the USA
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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]. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 12,534 cartons, 125,340 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-0372-2019.
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