December 2021 FDA Recall Drug by Organics Corporation Of America Dba Ambix Laboratories
D-0559-2022 - MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT

This Class II drug recall was voluntarily initiated by Organics Corporation Of America Dba Ambix Laboratories on December 6, 2021 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed in The product went to one consignee. Natural Organics, Inc., 548 Broadhollow Rd., Melville, NY 11747. and the recall is currently ongoing.

Recall Number: D-0559-2022

Reason for Recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Initiated
12-06-2021
Reported
02-23-2022
Quantity
4,214 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89231
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Organics Corporation of America DBA Ambix Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
The product went to one consignee. Natural Organics, Inc., 548 Broadhollow Rd., Melville, NY 11747.
Product Description About Product Description
Full technical description of the product.
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA

Batch or Lot Expiration Information

Lot# Product code 4929
Lot# 23622