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Recall Observatory FDA recall evidence

Drug product

Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL

D-0623-2018

March 28, 2018

Class II

Product summary

Firm
Elroselabs Inc.
Event
Event 79606
Status
Terminated
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-0623-2018

Official wording

Reason: cGMP Deviations

Code information: All product within expiry

Distribution pattern: Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations