Why it was recalled
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Product description
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144
Lot numbers, UPCs & expiration codes
Lot #: a) 05J19, Exp 07/21; b) 05J19, Exp 07/21, 43L19, Exp 09/21; c) 43L19 Exp 09/21, 44L19 Exp 09/21
Where it was sold
USA Nationwide
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-1242-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2020
- FDA report date
- Apr 22, 2020
- Quantity
- 4790 tottles; 20,403 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Filltech USA, LLC
Original FDA data
Every field from FDA enforcement report D-1242-2020, exactly as published.
Show all FDA fields
- City
- Rockwell
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 85274
- Address
- 380 Palmer Cir
- Code information
- Lot #: a) 05J19, Exp 07/21; b) 05J19, Exp 07/21, 43L19, Exp 09/21; c) 43L19 Exp 09/21, 44L19 Exp 09/21
- Postal code
- 28138
- Report date
- Apr 22, 2020
- Product type
- Drugs
- Recall number
- D-1242-2020
- Classification
- Class II
- Recalling firm
- Filltech USA, LLC
- Product quantity
- 4790 tottles; 20,403 tubes
- Termination date
- Jan 14, 2022
- Reason for recall
- Microbial contamination of non-sterile products: positive test for yeast and bacteria.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 16, 2020