D-0751-2023 Class II Terminated
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