Reported Jan 16, 2019 · Terminated
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only,…
Sun Pharmaceutical Industries, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only
- Manufactured bySun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India
- Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]
- Lot codes and dates
Lot #: JKS0443AJKS0444AJKS0477AEXP 03/2019
- Amount recalled
- 12,534 cartons, 125,340 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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