CLASS I Drug recall · Reported 16 Jan 2019 · FDA Enforcement Report
Vecuronium Bromide for Injection 10 mg* recalled
Sun Pharmaceutical Industries is recalling Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to Lyophilized, mg, distributed nationwide in the US. The recall was initiated on 3 Jan 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0372-2019
- FDA event ID
- 81891
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Brand
- Vecuronium Bromide
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Jan 2019
- FDA classified
- 14 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Jan 2019 | Recall initiated by company | |
| 14 Jan 2019 | Classified by FDA | +11 days |
| 16 Jan 2019 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Product as listed by the FDA
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]
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Which lots are affected?
Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Vecuronium Bromide for Injection 20 mg* *1mg/mL when recalledVecuronium Bromide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
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All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Vecuronium recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | vecuronium, 10 mg/, (1 mg/mL) syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vecuronium Bromide for Injection, 10 mg recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Vecuronium Bromide for Injection 20 mg* *1mg/mL when recalledVecuronium Bromide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Vecuronium Bromide in Sterile Water for Injection recalled | Pharmedium Services | Sterility | Nationwide |