FDA recall D-0637-2017

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.

Reason for recall

Presence of Particulate Matter

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2017-02-08

Report date

2017-04-12

Termination date

2020-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horseheads, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0637-2017