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FDAFebruary 8, 2017drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of Particulate Matter

What to do

FDA enforcement status: Terminated

Brands named

x gen pharmaceuticals

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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