Reported Aug 7, 2019 · Terminated
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe,…
Piramal Critical Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Piramal Critical Care, Inc. · 3950 Schelden Cir · Bethlehem, PA · 18017-8936
Is this the product you have?
- Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe
- Distributed byPrimal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
- Lot codes and dates
Lot #: 2155-1112155-111AExp 6/20
- Amount recalled
- Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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