D-0729-2023 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
5627 bags

Product Description

EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7018-1.

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 # 37-883218, Exp 04/30/2023; 37-885235, Exp 05/08/2023; 37-885923, Exp 05/10/2023; 37-889050, Exp 05/23/2023; 37-890053, 37-890054, Exp 05/28/2023; 37-891439, 37-891441, Exp 06/01/2023; 37-892500, Exp 06/06/2023; 37-894308, Exp 06/13/2023; 37-896125, Exp 06/20/2023; 37-896926, Exp 06/22/2023; 37-900396, Exp 07/06/2023