D-0701-2023 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
3338 bags

Product Description

EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.

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 # 37-884448, Exp 05/04/2023; 37-887386, Exp 05/16/2023; 37-888271, Exp 05/21/2023; 37-891189, Exp 05/31/2023; 37-893456, Exp 06/11/2023; 37-894656, Exp 06/14/2023; 37-898333, Exp 06/28/2023; 37-898559, Exp 06/29/2023