D-0730-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- June 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2542 bags
Product Description
EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 37-884156, Exp 05/03/2023; 37-885207, Exp 05/08/2023; 37-885929, Exp 05/10/2023; 37-886496, Exp 05/14/2023; 37-886817, Exp 05/15/2023; 37-887420, Exp 05/16/2023; 37-893786, Exp 06/12/2023; 37-894303, Exp 06/13/2023; 37-897893, Exp 06/27/2023; 37-900073, Exp 07/05/2023