D-0746-2023 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
2992 bags

Product Description

heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1.

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 # 37-888833, Exp 05/02/2023; 37-890537, Exp 05/09/2023; 37-892161, 37-892163, Exp 05/16/2023; 37-893979, 37-893992, Exp 05/23/2023; 37-895755, 37-895758, Exp 05/30/2023