Piramal Critical Care, Inc. recalls Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Di
Recalled August 7, 2019 · FDA recall D-1742-2019 · Piramal Critical Care
Hazard
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. · FDA Class II
Units
Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
Sold at
USA Nationwide
Description
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.
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
Manufacturer(s)
Piramal Critical Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →