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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
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 # 37-884151, 37-884153, Exp 05/03/2023; 37-885670, 37-885869, 37-885900, Exp 05/09/2023; 37-886271, Exp 05/11/2023; 37-886857, 37-886862, 37-886865, 37-886923, Exp 05/15/2023; 37-889190, 37-889191, Exp 05/23/2023; 37-889596, Exp 05/24/2023; 37-890482, 37-890487, 37-890488, Exp 05/29/2023; 37-891230, Exp 05/31/2023; 37-892589, 37-892590, Exp 06/06/2023; 37-893779, 37-893780, 37-893781, Exp 06/12/2023; 37-894665, 37-894667, Exp 06/14/2023; 37-895608, 37-895625, Exp 06/19/2023; 37-896519, Exp 06/21/2023
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.