D-0027-2019 Class II Terminated
FDA drug recall D-0027-2019 was initiated by Product Quest Manufacturing LLC on August 3, 2018 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus. The recall status is terminated (terminated March 30, 2021). Affected quantity: 5025 sticks.
Recall Details
- Product Type
- Drugs
- Report Date
- October 24, 2018
- Initiation Date
- August 3, 2018
- Termination Date
- March 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5025 sticks
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.
Reason for Recall
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 172428G