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Recall Observatory FDA recall evidence

Drug product

Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

D-0073-2021

October 21, 2020

Class II

Product summary

Firm
H & H Remedies, LLC
Event
Event 86712
Status
Terminated
Classification
Class II
Quantity
252 jars
Official record key
drug-enforcement:D-0073-2021

Official wording

Reason: CGMP Deviations

Code information: Lot #: H20-01V thru H20-10V

Distribution pattern: Nationwide in the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations