FDAFDA · Food and drugs·Recall number D-1742-2019
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
Published August 7, 2019 · Recall initiated: July 8, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GABLOFEN
- Manufacturer
- Piramal Critical Care, Inc.
- Distributor
- USA Nationwide
- UPC
- 0366794157024
- Lot
- Lot #: 2155-111, 2155-111A, Exp 6/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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