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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
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 # 37-884448, Exp 05/04/2023; 37-887386, Exp 05/16/2023; 37-888271, Exp 05/21/2023; 37-891189, Exp 05/31/2023; 37-893456, Exp 06/11/2023; 37-894656, Exp 06/14/2023; 37-898333, Exp 06/28/2023; 37-898559, Exp 06/29/2023
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.