Gablofen Injection, Solution
FDA Recall NDC 66794-151
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 Gablofen (NDC 66794-151). A significant event, classified as Class II, was initiated on Jul 08, 2019 by Piramal Critical Care Inc. The reported reason for this action was: "Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product."
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
July 2019 Class II Recall: Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Jul 08, 2019
Aug 07, 2019
Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
Recall Profile & Regulatory Data
Event ID
83280
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Piramal Critical Care, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Mar 09, 2021
Product Description
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
Batch or Lot Expiration Information
Lot# : 2155-111, 2155-111A, Exp 6/20
Affected Packages Involved in this Recall
66794-151-01Product
66794-155-01Product
66794-155-02Product
66794-156-01Product
66794-156-02Product
66794-157-01Product
66794-157-02Product
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.
