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Recall Observatory FDA recall evidence

Drug product

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

D-1742-2019

July 08, 2019

Class II

Product summary

Firm
Piramal Critical Care, Inc.
Event
Event 83280
Status
Terminated
Classification
Class II
Quantity
Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
Official record key
drug-enforcement:D-1742-2019

Official wording

Reason: 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.

Code information: Lot #: 2155-111, 2155-111A, Exp 6/20

Distribution pattern: USA Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specification