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

FDA recall notice · announced August 7, 2019 · Piramal Critical Care

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

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.

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: 2155-111, 2155-111A, Exp 6/20
Quantity: Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
Status: Terminated
Products in this recall event:
- 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, 18 (D-1742-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.