D-0701-2023 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
- 3338 bags
Product Description
EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
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 # 37-884448, Exp 05/04/2023; 37-887386, Exp 05/16/2023; 37-888271, Exp 05/21/2023; 37-891189, Exp 05/31/2023; 37-893456, Exp 06/11/2023; 37-894656, Exp 06/14/2023; 37-898333, Exp 06/28/2023; 37-898559, Exp 06/29/2023