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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
EPINEPHrine added to dextrose 5%, 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 71285-7018-1.
Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification
Class II
Status
Terminated
Lot
Lot # 37-883218, Exp 04/30/2023; 37-885235, Exp 05/08/2023; 37-885923, Exp 05/10/2023; 37-889050, Exp 05/23/2023; 37-890053, 37-890054, Exp 05/28/2023; 37-891439, 37-891441, Exp 06/01/2023; 37-892500, Exp 06/06/2023; 37-894308, Exp 06/13/2023; 37-896125, Exp 06/20/2023; 37-896926, Exp 06/22/2023; 37-900396, Exp 07/06/2023
Date
2023-05-31
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.