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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025

D-1040-2017

July 12, 2017

Class II

Product summary

Firm
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Event
Event 77757
Status
Terminated
Classification
Class II
Quantity
120 vials
Official record key
drug-enforcement:D-1040-2017

Official wording

Reason: CGMP Deviations

Code information: Lot # 03022017+44906; BUD 08/29/17

Distribution pattern: There were only one customer in California

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations