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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30

D-0214-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
580 vials and 30000 milliliters
Official record key
drug-enforcement:D-0214-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 02272018:63/A Discard by: 2/22/2019; 08162018:63/A Discard by: 4/30/2019; 10092017:30 Discard by: 10/1/2018; 02272018:63 Discard by: 2/22/2019; 08162018:63 Discard by: 4/30/2019

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility