Drug 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.
D-0637-2017
Product summary
- Event
- Event 76410
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2593 cartons
- Official record key
drug-enforcement:D-0637-2017
Official wording
Reason: Presence of Particulate Matter
Code information: PLND1613, Exp 02/18
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter