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
Reported: August 7, 2019 Initiated: July 8, 2019 #D-1742-2019
Product Description
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.
Details
- Recalling Firm
- Piramal Critical Care, Inc.
- Units Affected
- Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
- Distribution
- USA Nationwide
- Location
- Bethlehem, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Piramal Critical Care, Inc.. Units affected: Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2019. Severity: Moderate. Recall number: D-1742-2019.
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