FDA-Drug2019-08-07Class II
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
Piramal Critical Care, Inc.
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.
Sold states
USA Nationwide
Affected count
Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
Manufactured in
3950 Schelden Cir, N/A, Bethlehem, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1742-2019Don't want to check this manually?
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