Home / Recalls / Piramal Critical Care, Inc. / D-1742-2019

D-1742-2019 Class II Terminated

Recalled by Piramal Critical Care, Inc. — Bethlehem, PA

Recall Details

Product Type: Drugs
Report Date: August 7, 2019
Initiation Date: July 8, 2019
Termination Date: March 9, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)

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

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.

Distribution Pattern

USA Nationwide

Code Information

Lot #: 2155-111, 2155-111A, Exp 6/20