Recalls / Class II
Class IID-1742-2019
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
- Brand name
- Gablofen
- Generic name
- Baclofen Injection
- Active ingredient
- Baclofen
- Route
- Intrathecal
- NDCs
- 66794-151, 66794-155, 66794-156, 66794-157
- FDA application
- NDA022462
- Affected lot / code info
- Lot #: 2155-111, 2155-111A, Exp 6/20
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.
Recalling firm
- Firm
- Piramal Critical Care, Inc.
- Manufacturer
- Piramal Critical Care Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3950 Schelden Cir, N/A, Bethlehem, Pennsylvania 18017-8936
Distribution
- Quantity
- Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2019-07-08
- FDA classified
- 2019-08-13
- Posted by FDA
- 2019-08-07
- Terminated
- 2021-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1742-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.