Ibuprofen Lysine Solution
FDA Recall NDC 39822-1030
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ibuprofen Lysine (NDC 39822-1030). A significant event, classified as Class I, was initiated on Feb 08, 2017 by Xgen Pharmaceuticals Djb, Inc.. The reported reason for this action was: "Presence of Particulate Matter"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter
Feb 08, 2017
Apr 12, 2017
2593 cartons
Recall Profile & Regulatory Data
Event ID
76410
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
X-Gen Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jun 10, 2020
Product Description
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
39822-1030-1Product
39822-1030-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
