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Recall Observatory FDA recall evidence

Drug product

TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0192-81

D-1713-2019

June 19, 2019

Class II

Product summary

Firm
RXQ Compounding LLC
Event
Event 83074
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1713-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots within expiry

Distribution pattern: Nationwide USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility