D-0743-2023 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
- 2890 bags
Product Description
NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.
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 # 37-883007, 37-883015, 37-883017, Exp 04/28/2023; 37-883236, Exp 04/30/2023; 37-884187, 37-884189, 37-884190, Exp 05/03/2023; 37-884567, 37-884568, 37-884569, Exp 05/04/2023; 37-887789, 37-887790, Exp 05/17/2023; 37-889142, 37-889143, 37-889144, 37-889149, Exp 05/23/2023; 37-889606, Exp 05/24/2023; 37-890519, 37-890528, Exp 05/29/2023; 37-890946, 37-890951, Exp 05/30/2023; 37-891281, 37-891284, 37-891292, 37-891294, Exp 05/31/2023; 37-891756, 37-891757, Exp 06/04/2023; 37-897959, 37-897961, Exp 06/27/2023; 37-898795, Exp 07/02/2023