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.
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
Lot numbers, UPCs & expiration codes
Lot #: 2155-111, 2155-111A, Exp 6/20
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1742-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 8, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Piramal Critical Care, Inc.
Original FDA data
Every field from FDA enforcement report D-1742-2019, exactly as published.
Show all FDA fields
- City
- Bethlehem
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 83280
- Address
- 3950 Schelden Cir
- Code information
- Lot #: 2155-111, 2155-111A, Exp 6/20
- Postal code
- 18017-8936
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1742-2019
- Classification
- Class II
- Recalling firm
- Piramal Critical Care, Inc.
- Product quantity
- Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
- Termination date
- Mar 9, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 8, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2019