FDA-Drug2017-04-12Class I
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 by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
X-Gen Pharmaceuticals Inc.
Hazard
Presence of Particulate Matter
Sold states
Nationwide in the USA.
Affected count
2593 cartons
Manufactured in
300 Daniel Zenker Dr, N/A, Horseheads, NY, United States
Products
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 by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2017Don't want to check this manually?
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