D-1044-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 15, 2018
- Initiation Date
- July 24, 2018
- Termination Date
- December 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 Syringes
Product Description
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
Reason for Recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Distribution Pattern
Product was distributed throughout the United States
Code Information
Lot 181730039D, Exp 09/20/2018