Central Admixture Pharmacy Services, Inc. — Class II Recall

Product

heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.

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 # 37-888736, 37-888769, Exp 05/02/2023; 37-890465, 37-890483, Exp 05/09/2023; 37-892088, 37-892117, 37-892119, 37-892145, Exp 05/16/2023; 37-893759, 37-893765, Exp 05/23/2023; 37-895742, 37-895751, 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.