D-0751-2023 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
3165 bags

Product Description

Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.

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 # 37-883239, 37-883240, Exp 05/01/2023; 37-884419, 37-884423, Exp 05/04/2023; 37-889009, Exp 05/23/2023; 37-890261, 37-890262, Exp 05/29/2023; 37-891250, Exp 05/31/2023; 37-891412, Exp 06/01/2023; 37-895488, Exp 06/19/2023; 37-896456, Exp 06/21/2023; 37-898159, Exp 06/28/2023