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Recall Observatory FDA recall evidence

Drug product

Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

D-1337-2019

May 23, 2019

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 82941
Status
Terminated
Classification
Class II
Quantity
371 vials
Official record key
drug-enforcement:D-1337-2019

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: 01312019:02 Exp. 08/16/2019; 02072019:45/A Exp. 11/30/2019

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility