Reported Apr 12, 2017 · Terminated
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL…
X-Gen Pharmaceuticals 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: X-Gen Pharmaceuticals Inc. · 300 Daniel Zenker Dr · Horseheads, NY · 14845-1014
Is this the product you have?
- Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only
- Distributed byX-Gen Pharmaceuticals, Inc., Big Flats, NY 14814
- Manufactured byExela Pharma Sciences, LLC, Lenoir, NC 28645
- Lot codes and dates
PLND1613Exp 02/18
- Amount recalled
- 2593 cartons
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter
Using this product could cause serious injury, illness or death — stop using it now.
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