December 2014 FDA Recall Drug by Tropichem Research Labs, Inc.
D-0328-2015 - Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli

This Class II drug recall was voluntarily initiated by Tropichem Research Labs, Inc. on December 17, 2014 for the product Drug. The FDA reported the reason for recall as microbial contamination of non sterile product; microbial assay reported unacceptable high plate counts and positive for e. coli. The product was distributed in NY and IN. and the recall is currently terminated.

Recall Number: D-0328-2015

Reason for Recall
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Initiated
12-17-2014
Reported
01-07-2015
Quantity
24,348 / 2 oz. bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70084
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tropichem Research Labs, Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY and IN.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-04-2017
Product Description About Product Description
Full technical description of the product.
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN

Batch or Lot Expiration Information

Lot# Lot No. 141010, Best By Date: 10/2016; UPC Code: 728409847025