Central Admixture Pharmacy Services, Inc. — Class II Recall

Product

PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1.

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 # 37-883924, Exp 05/02/2023; 37-884918, Exp 05/07/2023; 37-885677, Exp 05/09/2023; 37-887318, Exp 05/16/2023; 37-889211, Exp 05/23/2023; 37-889848, Exp 05/25/2023; 37-891150, Exp 05/31/2023; 37-892482, Exp 06/06/2023; 37-894484, Exp 06/13/2023; 37-896458, 37-896480, Exp 06/21/2023; 37-897967, Exp 06/27/2023; 37-898551, Exp 06/29/2023

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.