Vecuronium Bromide Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 47335-932
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Vecuronium Bromide (NDC 47335-932). A significant event, classified as Class I, was initiated on Jan 03, 2019 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Jan 03, 2019
Jan 16, 2019
1,384 cartons, 13,840 vials
Recall Profile & Regulatory Data
Event ID
81891
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 03, 2021
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]
Batch or Lot Expiration Information
Lot# : JKS0400A, EXP 03/2019
Affected Packages Involved in this Recall
47335-931-40Product
47335-931-44Product
47335-932-40Product
47335-932-44Product
Class I Terminated
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Jan 03, 2019
Jan 16, 2019
12,534 cartons, 125,340 vials
Recall Profile & Regulatory Data
Event ID
81891
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 03, 2021
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]
Batch or Lot Expiration Information
Lot# : JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
Affected Packages Involved in this Recall
47335-931-40Product
47335-931-44Product
47335-932-40Product
47335-932-44Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
