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Recall Observatory FDA recall evidence

Drug product

Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com.

D-0034-2024

August 26, 2023

Class II

Product summary

Firm
Dr. Berne's Whole Health Products
Event
Event 92952
Status
Ongoing
Classification
Class II
Quantity
795 bottles
Official record key
drug-enforcement:D-0034-2024

Official wording

Reason: CGMP Deviations

Code information: Lot: 6617, Exp. 05/24; 6623, Exp 06/24; 6646, Exp 07/24; 6675, Exp 09/24; 6716, Exp 11/24.

Distribution pattern: Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations