July 2019 FDA Recall Gablofen by Piramal Critical Care, Inc.
D-1742-2019 - 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 Class II drug recall was voluntarily initiated by Piramal Critical Care, Inc. on July 8, 2019 for the product Gablofen. The FDA reported the reason for recall as 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.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1742-2019

Reason for 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.
Initiated
07-08-2019
Reported
08-07-2019
Quantity
Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83280
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Piramal Critical Care, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-09-2021
Product Description About Product Description
Full technical description of the product.
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

66794-151-01 Gablofen
66794-155-01 Gablofen
66794-155-02 Gablofen
66794-156-01 Gablofen
66794-156-02 Gablofen
66794-157-01 Gablofen
66794-157-02 Gablofen