Recalls / Class II
Class IID-0743-2023
Product
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.
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6580 Snowdrift Rd Ste 100, N/A, Allentown, Pennsylvania 18106-9331
Distribution
- Quantity
- 2890 bags
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-04-28
- FDA classified
- 2023-05-19
- Posted by FDA
- 2023-05-31
- Terminated
- 2025-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0743-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.