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Recall Observatory FDA recall evidence

Drug product

Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05

D-0209-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
40 milliliters
Official record key
drug-enforcement:D-0209-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 04262018:08 Discard by: 10/22/2018; 07242018:81 Discard by: 1/20/2019

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility