Recalls / Class II
Class IID-0742-2023
Product
EPINEPHrine 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 71285-8093-1.
- Affected lot / code info
- Lot # 37-882988, Exp 04/28/2023; 37-883194, 37-883208, Exp 04/30/2023; 37-884746, Exp 05/05/2023; 37-885215, Exp 05/08/2023; 37-885927, Exp 05/10/2023; 37-887044, 37-887051, Exp 05/15/2023; 37-887667, Exp 05/17/2023; 37-888297, 37-888298, Exp 05/21/2023; 37-890886, Exp 05/30/2023; 37-891438, Exp 06/01/2023; 37-892497, Exp 06/06/2023; 37-893159, Exp 06/08/2023; 37-893843, Exp 06/12/2023; 37-894649, Exp 06/14/2023; 37-896928, Exp 06/22/2023; 37-899304, Exp 07/03/2023
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
- 8171 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-0742-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.