D-0740-2023 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
2186 bags

Product Description

oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.

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 # 37-886265, Exp 05/11/2023; 37-886266, Exp 05/11/2023; 37-889903, Exp 05/25/2023; 37-890551, Exp 05/29/2023; 37-892521, 37-892620, Exp 06/06/2023; 37-896246, 37-896247, Exp 06/20/2023; 37-898553, Exp 06/29/2023