heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx ...
FDA Recall #D-0726-2023 — Class II — April 28, 2023
Product Description
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 for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3055 bags
Distribution
Nationwide in the USA.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated