D-0904-2018 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
Product Description
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), 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 # 20180329@2, Exp 06/27/2018