Drug recall D-1742-2019
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
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.
Lots and codes
Lot #: 2155-111, 2155-111A, Exp 6/20
Recall details
- Recalling firm
- Piramal Critical Care, Inc., Bethlehem, PA
- Quantity
- Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 8, 2019
- Terminated
- March 9, 2021
Related products
- Gablofen – drug information
- NDC 66794-156 Gablofen · Baclofen 1000 ug/mL · Piramal Critical Care Inc
- NDC 66794-151 Gablofen · Baclofen 50 ug/mL · Piramal Critical Care Inc
- NDC 66794-155 Gablofen · Baclofen 500 ug/mL · Piramal Critical Care Inc
- NDC 66794-157 Gablofen · Baclofen 2000 ug/mL · Piramal Critical Care Inc