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Recall Observatory FDA recall evidence

Drug product

HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

D-1098-2015

May 18, 2015

Class II

Product summary

Firm
Advanced Physician Solutions, Inc.
Event
Event 71205
Status
Terminated
Classification
Class II
Quantity
28 vials
Official record key
drug-enforcement:D-1098-2015

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility