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Recall Observatory FDA recall evidence

Drug product

Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409

D-0611-2020

May 30, 2019

Class II

Product summary

Firm
Surgery Pharmacy Services Inc
Event
Event 84401
Status
Terminated
Classification
Class II
Quantity
84 bags
Official record key
drug-enforcement:D-0611-2020

Official wording

Reason: Lack of sterility assurance.

Code information: RX numbers from 311976 to 314888

Distribution pattern: Distributed in GA, TN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility