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Recall Observatory FDA recall evidence

Drug product

S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx

D-0279-2020

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
N/A
Official record key
drug-enforcement:D-0279-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #:a) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/29/19; S06092019DH@08, Exp 10/9/19, S06252019DH@15, Exp 10/25/19; S07022019DH@10, Exp 11/2/19, S07292019DH@11, Exp 11/29/19; b) S06032019DT@02, Exp 10/3/19; S07232019DH@03, Exp 11/23/19

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility