Drug product
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.
D-0751-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3165 bags
- Official record key
drug-enforcement:D-0751-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility