February 2017 FDA Recall Ibuprofen Lysine by X-gen Pharmaceuticals Inc.
D-0637-2017 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by X-gen Pharmaceuticals Inc. on February 8, 2017 for the product Ibuprofen Lysine. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0637-2017

Reason for Recall
Presence of Particulate Matter
Initiated
02-08-2017
Reported
04-12-2017
Quantity
2593 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76410
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
X-Gen Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# PLND1613, Exp 02/18

Affected Packages Involved in this Recall

39822-1030-1 Ibuprofen Lysine
39822-1030-2 Ibuprofen Lysine