Recalls / Class II
Class IID-0745-2023
Product
NORepinephrine added to 0.9% sodium chloride, 4 mg/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 71285-8097-1.
- Affected lot / code info
- Lot # 37-884510, Exp 05/04/2023; 37-885671, Exp 05/09/2023; 37-886285, Exp 05/11/2023; 37-888322, Exp 05/21/2023; 37-888851, Exp 05/22/2023; 37-889840, Exp 05/25/2023; 37-890130, Exp 05/28/2023; 37-890966, Exp 05/30/2023; 37-893529, Exp 06/11/2023; 37-894766, Exp 06/14/2023; 37-895300, 37-895301, Exp 06/18/2023; 37-898521, Exp 06/29/2023; 37-900338, Exp 07/06/2023
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
- 4994 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-0745-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.