Why it was recalled
Out of Specification for active ingredient
Product description
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
Lot numbers, UPCs & expiration codes
Lot 04023C1, Exp 01/31/2025
Where it was sold
Distributed 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-0523-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 17, 2024
- FDA report date
- Jun 5, 2024
- Quantity
- 4,013
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ARG Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0523-2024, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 94354
- Address
- 2639 Manana Dr
- Code information
- Lot 04023C1, Exp 01/31/2025
- Postal code
- 75220-1301
- Report date
- Jun 5, 2024
- Product type
- Drugs
- Recall number
- D-0523-2024
- Classification
- Class II
- Recalling firm
- ARG Laboratories, Inc.
- Product quantity
- 4,013
- Reason for recall
- Out of Specification for active ingredient
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Apr 17, 2024
- Initial firm notification
- Letter
- Center classification date
- May 30, 2024