D-0718-2023 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
3075 bags

Product Description

vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.

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 # 37-884161, Exp 05/03/2023; 37-885995, 37-885997, Exp 05/10/2023; 37-887729, Exp 05/17/2023; 37-889595, Exp 05/24/2023; 37-891272, Exp 05/31/2023; 37-892162, Exp 06/05/2023; 37-894716, Exp 06/14/2023