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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
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 # 37-885553, 37-885554, Exp 05/09/2023; 37-887923, 37-887924, Exp 05/18/2023; 37-890778, 37-890779, Exp 05/30/2023; 37-892847, Exp 06/07/2023; 37-895049, Exp 06/15/2023; 37-898480, 37-898481, 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.