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Recall Observatory FDA recall evidence

Drug product

Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.

D-0508-2020

November 12, 2019

Class II

Product summary

Firm
Integrated Health Concepts Inc. dba Conversio Health
Event
Event 84284
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0508-2020

Official wording

Reason: Lack of Processing Controls

Code information: All Lots

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls