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Recall Observatory FDA recall evidence

Drug product

Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05

D-0210-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
521 syringes
Official record key
drug-enforcement:D-0210-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 04192018:22 Discard by: 5/17/2018; 04022018:47 Discard by: 4/23/2018; 05102018:77 Discard by: 6/7/2018; 08022018:63 Discard by: 8/30/2018; 08272018:66 Discard by: 9/24/2018

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility