D-0714-2023 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
- 2041 bags
Product Description
norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6056-1.
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 # 37-884760, Exp 05/05/2023; 37-885601, Exp 05/09/2023; 37-887668, Exp 05/17/2023; 37-889594, Exp 05/24/2023; 37-892622, Exp 06/06/2023; 37-894316, Exp 06/13/2023