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Recall Observatory FDA recall evidence

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

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility