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Class II: temporary or reversible health riskTerminated

Tropichem Research Labs Entertainer's Secret Throat Relief Recall

Entertainer's Secret Throat Relief, 2

Tropichem Research Labs, Inc. · Jupiter, FL

Risk level
Class II
Reported by FDA
Jan 7, 2015
Recall ID
D-0328-2015
Check your lot numberHow we source this data

Summary

Tropichem Research Labs recalled Entertainer's Secret Throat Relief starting Dec 17, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0328-2015 on Jan 7, 2015. Reason: Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli. Status: Terminated.

Why it was recalled

Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli

Product description

Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN

Lot numbers, UPCs & expiration codes

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

Where it was sold

NY and IN.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0328-2015
Classification
Class II
Status
Terminated
Recall initiated
Dec 17, 2014
FDA report date
Jan 7, 2015
Quantity
24,348 / 2 oz. bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Tropichem Research Labs, Inc.

Original FDA data

Every field from FDA enforcement report D-0328-2015, exactly as published.

Show all FDA fields
City
Jupiter
State
FL
Status
Terminated
Country
United States
Event ID
70084
Address
15843 Guild Ct
Code information
Lot No. 141010, Best By Date: 10/2016; UPC Code: 728409847025
Postal code
33478-6436
Report date
Jan 7, 2015
Product type
Drugs
Recall number
D-0328-2015
Classification
Class II
Recalling firm
Tropichem Research Labs, Inc.
Product quantity
24,348 / 2 oz. bottles
Termination date
May 4, 2017
Reason for recall
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Voluntary / mandated
Voluntary: Firm initiated
Product description
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
Distribution pattern
NY and IN.
Recall initiation date
Dec 17, 2014
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Dec 29, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0328-2015, published Jan 7, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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