D-0726-2023 Class II Terminated

Recalled by Central Admixture Pharmacy Services, Inc. — Allentown, PA

Recall Details

Product Type
Drugs
Report Date
May 31, 2023
Initiation Date
April 28, 2023
Termination Date
June 22, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3055 bags

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.

Distribution Pattern

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