Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gablofen (baclofen injection) Recalled by Piramal Critical Care, Inc. Due to Failed Impurities/Degradation Specification -This recall is being initiated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Piramal Critical Care, Inc. directly.
Affected 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
Quantity: Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Piramal Critical Care, Inc.
Piramal Critical Care, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report