FDA Recall D-0637-2017
X-Gen Pharmaceuticals Inc. · Horseheads, NY
Class I — life-threatening Terminated 1218 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0637-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2017-02-08
- Classified by FDA Center
- 2017-04-05
- FDA published
- 2017-04-12
- Terminated
- 2020-06-10
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Firm location
- Horseheads, NY
Drug identification
- Brand name(s)
- IBUPROFEN LYSINE
- Generic name(s)
- IBUPROFEN LYSINE
- Manufacturer(s)
- XGen Pharmaceuticals DJB, Inc.
- NDC(s)
39822-1030- Route(s)
- INTRAVENOUS