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Recall Observatory FDA recall evidence

Drug product

S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx,

D-0270-2020

August 12, 2019

Class II

Product summary

Firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Event
Event 83669
Status
Terminated
Classification
Class II
Quantity
6 vials
Official record key
drug-enforcement:D-0270-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #:S07092019DT@20, Exp 10/9/19; S07242019DH@08, Exp 10/24/19

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility