Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: Vecuronium Bromide for Injection Recalled Due to Glass Particulate Matter

Agency Publication Date: January 10, 2019

Summary

Sun Pharmaceutical Industries, Inc. is recalling 13,918 units of Vecuronium Bromide for Injection (10 mg and 20 mg vials) because glass fragments were detected within the medication. This injectable drug is a generic neuromuscular blocking agent used during surgery or for patients on ventilators. If glass particles are injected, they can cause serious health issues including inflammation, blood clots, or damage to vital organs. Consumers and healthcare providers should check their stock for the specific lots affected and stop using them immediately.

Risk

The presence of glass particulate matter in an injectable medication can cause local irritation or inflammation, but more seriously, the particles can travel through the bloodstream and lead to the formation of blood clots or blockages in the lungs, heart, or brain.

What You Should Do

Immediately check your inventory for Vecuronium Bromide for Injection 10 mg vials with lot numbers JKS0443A, JKS0444A, or JKS0477A and an expiration date of 03/2019.
Check your inventory for Vecuronium Bromide for Injection 20 mg vials with lot number JKS0400A and an expiration date of 03/2019.
Identify the products by their NDC numbers: NDC 47335-931-40 (10 mg vial), NDC 47335-931-44 (10 mg carton), NDC 47335-932-40 (20 mg vial), or NDC 47335-932-44 (20 mg carton).
Stop using any affected medication immediately and quarantine it to prevent accidental administration.
Contact your healthcare provider or pharmacist for guidance if you believe you have received this medication, and return any unused product to the pharmacy for a refund.
Contact Sun Pharmaceutical Industries, Inc. for further instructions regarding the return process and to report any adverse events.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Vecuronium Bromide for Injection (10 mg)

Model:

NDC 47335-931-40

NDC 47335-931-44

Lot Numbers:

JKS0443A (Exp 03/2019)

JKS0444A (Exp 03/2019)

JKS0477A (Exp 03/2019)

Date Ranges: EXP 03/2019

Product: Vecuronium Bromide for Injection (20 mg)

Model:

NDC 47335-932-40

NDC 47335-932-44

Lot Numbers:

JKS0400A (Exp 03/2019)

Date Ranges: EXP 03/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81891

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: hospitals; pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 2 products (12,534 cartons, 125,340 vials; 1,384 cartons, 13,840 vials)

Distributed To: Nationwide

Agency Last Updated: January 14, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your inventory for Vecuronium Bromide for Injection 10 mg vials with lot numbers JKS0443A, JKS0444A, or JKS0477A and an expiration date of 03/2019.

Check your inventory for Vecuronium Bromide for Injection 20 mg vials with lot number JKS0400A and an expiration date of 03/2019.

Identify the products by their NDC numbers: NDC 47335-931-40 (10 mg vial), NDC 47335-931-44 (10 mg carton), NDC 47335-932-40 (20 mg vial), or NDC 47335-932-44 (20 mg carton).

Stop using any affected medication immediately and quarantine it to prevent accidental administration.

Contact your healthcare provider or pharmacist for guidance if you believe you have received this medication, and return any unused product to the pharmacy for a refund.

Contact Sun Pharmaceutical Industries, Inc. for further instructions regarding the return process and to report any adverse events.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Vecuronium Bromide for Injection (10 mg)

Model:

NDC 47335-931-40

NDC 47335-931-44

Lot Numbers:

JKS0443A (Exp 03/2019)

JKS0444A (Exp 03/2019)

JKS0477A (Exp 03/2019)

Date Ranges: EXP 03/2019

Product: Vecuronium Bromide for Injection (20 mg)

Model:

NDC 47335-932-40

NDC 47335-932-44

Lot Numbers:

JKS0400A (Exp 03/2019)

Date Ranges: EXP 03/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81891

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries, Inc.

Sold By: hospitals; pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 2 products (12,534 cartons, 125,340 vials; 1,384 cartons, 13,840 vials)

Distributed To: Nationwide

Agency Last Updated: January 14, 2019