FDA Recall D-0559-2022

Organics Corporation of America DBA Ambix Laboratories · Totowa, NJ

Class II Ongoing 1620 days on record

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

Product

NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA

Lot / code: Product code 4929, Lot # 23622

Quantity: 4,214 tubes

Reason for recall

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.

Recall record

Recall number: D-0559-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: The product went to one consignee. Natural Organics, Inc., 548 Broadhollow Rd., Melville, NY 11747.
Recall initiated: 2021-12-06
Classified by FDA Center: 2022-02-14
FDA published: 2022-02-23
Recalling firm: Organics Corporation of America DBA Ambix Laboratories
Firm location: Totowa, NJ

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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