Recalls / Class I
Class ID-0637-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Ibuprofen Lysine
- Generic name
- Ibuprofen Lysine
- Active ingredient
- Ibuprofen Lysine
- Route
- Intravenous
- NDC
- 39822-1030
- FDA application
- ANDA202402
- Affected lot / code info
- PLND1613, Exp 02/18
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- X-Gen Pharmaceuticals Inc.
- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 300 Daniel Zenker Dr, N/A, Horseheads, New York 14845-1014
Distribution
- Quantity
- 2593 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2017-02-08
- FDA classified
- 2017-04-05
- Posted by FDA
- 2017-04-12
- Terminated
- 2020-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0637-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.