Central Admixture Pharmacy Services, Inc. — Class II Recall

Product

NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.

Reason

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

Classification

Class II

Status

Terminated

Lot

Lot # 37-883007, 37-883015, 37-883017, Exp 04/28/2023; 37-883236, Exp 04/30/2023; 37-884187, 37-884189, 37-884190, Exp 05/03/2023; 37-884567, 37-884568, 37-884569, Exp 05/04/2023; 37-887789, 37-887790, Exp 05/17/2023; 37-889142, 37-889143, 37-889144, 37-889149, Exp 05/23/2023; 37-889606, Exp 05/24/2023; 37-890519, 37-890528, Exp 05/29/2023; 37-890946, 37-890951, Exp 05/30/2023; 37-891281, 37-891284, 37-891292, 37-891294, Exp 05/31/2023; 37-891756, 37-891757, Exp 06/04/2023; 37-897959, 37-897961, Exp 06/27/2023; 37-898795, Exp 07/02/2023

Date

2023-05-31

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.