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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2

D-0984-2020

January 15, 2020

Class II

Product summary

Firm
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Event
Event 84978
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0984-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 03062019+51706, Exp 6/28/2020

Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility