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Recall Observatory FDA recall evidence

Drug product

potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1.

D-0728-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
2146 bags
Official record key
drug-enforcement:D-0728-2023

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 # 37-883219, Exp 04/30/2023; 37-885926, Exp 05/10/2023; 37-887382, Exp 05/16/2023; 37-889455, Exp 05/24/2023; 37-890060, Exp 05/28/2023; 37-893444, Exp 06/11/2023; 37-894987, Exp 06/15/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility