Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.

Recall Number: D-0681-2023

Firm: Central Admixture Pharmacy Services, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230531

Initiation Date: 20230428

Termination Date: 20250622

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.