FDA Recall D-0033-2024

Dr. Berne's Whole Health Products · Tesuque, NM

Class II Ongoing 992 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001036

Lot / code: Lots: 6486, Exp: 11/23; 6536, Exp: 01/24; 6549, Exp: 02/24; 6561, Exp: 03/24; 6623, Exp: 06/24; 6630, Exp: 06/24; 6646, Exp: 07/24; 6675, Exp: 09/24; 6686, Exp: 09/24; 6695, Exp: 10/24; 6738, Exp: 11/24; 6767, Exp: 01/25; 6787, Exp: 03/25; 6799, Exp: 04/25; 6832 Exp: 05/25; 6844, Exp: 05/25; 6857, Exp: 06/25; 6888, Exp: 07/25.

Quantity: 6060 bottles

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0033-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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.
Recall initiated: 2023-08-26
Classified by FDA Center: 2023-10-04
FDA published: 2023-10-11
Recalling firm: Dr. Berne's Whole Health Products
Firm location: Tesuque, NM

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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