RecallHawk
Class II Recall

NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for Nature

Organics Corporation of America DBA Ambix Laboratories

Summary

The FDA issued a Class II for NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cr by Organics Corporation of America DBA Ambix Laboratories. Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae..

Details

Source

Drug Recall

External ID

D-0559-2022

Action Date

2022-02-23

Status

Ongoing

Category

drug

Product Description

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 Info: Product code 4929, Lot # 23622

Quantity Affected: 4,214 tubes

Reason for Recall

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

Distribution

The product went to one consignee. Natural Organics, Inc., 548 Broadhollow Rd., Melville, NY 11747.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-12-06

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Organics Corporation of America DBA Ambix Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Organics Corporation of America DBA Ambix Laboratories have FDA actions?

This is the only FDA action we have on record for Organics Corporation of America DBA Ambix Laboratories in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0559-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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