D-0708-2023 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
3865 bags

Product Description

oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.

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 # 37-883926, Exp 05/02/2023; 37-886032, Exp 05/10/2023; 37-887681, Exp 05/17/2023; 37-888317, Exp 05/21/2023; 37-890906, Exp 05/30/2023; 37-892146, Exp 06/05/2023; 37-892507, Exp 06/06/2023; 37-894483, Exp 06/13/2023; 37-896595, Exp 06/21/2023; 37-898568, Exp 06/29/2023