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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
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 # 37-885351, Exp 05/08/2023; 37-885979, Exp 05/10/2023; 37-887721, Exp 05/17/2023; 37-889212, Exp 05/23/2023; 37-889607, Exp 05/24/2023; 37-891247, Exp 05/31/2023; 37-892937, Exp 06/07/2023; 37-894025, Exp 06/12/2023; 37-894748, Exp 06/14/2023; 37-895282, Exp 06/18/2023; 37-896173, Exp 06/20/2023
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.