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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.
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 # 37-888668, 37-888685, 37-888701, Exp 05/02/2023; 37-890550, 37-890556, Exp 05/09/2023; 37-892201, 37-892216, Exp 05/16/2023; 37-893866, 37-893917, 37-893918, Exp 05/23/2023; 37-895705, 37-895717, Exp 05/30/2023
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.