X-Gen Pharmaceuticals Inc. recalls 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
Recalled April 12, 2017 · FDA recall D-0637-2017 · X-Gen Pharmaceuticals
Hazard
Presence of Particulate Matter · FDA Class I
Units
2593 cartons
Sold at
Nationwide in the USA.
Description
Presence of Particulate Matter
Product
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.
Manufacturer(s)
X-Gen Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →