FDA recall D-1742-2019

Piramal Critical Care, Inc. · Class II · drug

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.

Distribution

USA Nationwide

Key facts

Status: Terminated
Initiation date: 2019-07-08
Report date: 2019-08-07
Termination date: 2021-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1742-2019