D-0895-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2018
- Initiation Date
- June 14, 2018
- Termination Date
- February 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 492 bags
Product Description
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Reason for Recall
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018