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Class II: temporary or reversible health riskTerminated

Product Quest Manufacturing Dermatone Recall

DERMATONE (titanium oxide 6% and zinc oxide 4

Product Quest Manufacturing LLC · Daytona Beach, FL

Risk level
Class II
Reported by FDA
Oct 24, 2018
Recall ID
D-0027-2019
Check your lot numberHow we source this data

Summary

Product Quest Manufacturing recalled Dermatone starting Aug 3, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0027-2019 on Oct 24, 2018. Reason: Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus. Status: Terminated.

Why it was recalled

Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.

Product description

DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.

Lot numbers, UPCs & expiration codes

Lot: 172428G

Where it was sold

Nationwide in the USA

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-0027-2019
Classification
Class II
Status
Terminated
Recall initiated
Aug 3, 2018
FDA report date
Oct 24, 2018
Quantity
5025 sticks
Recall type
Voluntary: Firm initiated
Recalling firm
Product Quest Manufacturing LLC

Original FDA data

Every field from FDA enforcement report D-0027-2019, exactly as published.

Show all FDA fields
City
Daytona Beach
State
FL
Status
Terminated
Country
United States
Event ID
80750
Address
330 Carswell Ave
Code information
Lot: 172428G
Postal code
32117-4416
Report date
Oct 24, 2018
Product type
Drugs
Recall number
D-0027-2019
Classification
Class II
Recalling firm
Product Quest Manufacturing LLC
Product quantity
5025 sticks
Termination date
Mar 30, 2021
Reason for recall
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Voluntary / mandated
Voluntary: Firm initiated
Product description
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
Distribution pattern
Nationwide in the USA
Recall initiation date
Aug 3, 2018
Initial firm notification
Letter
Center classification date
Oct 16, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0027-2019, published Oct 24, 2018. 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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