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 Singl…

Recall date

February 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0637-2017

FDA classification

Class I

Brand / firm

X-Gen Pharmaceuticals Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

Presence of Particulate Matter

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.