Why it was recalled
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Product description
Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
Lot numbers, UPCs & expiration codes
Lot #: 12750, Exp 5/2021
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-1486-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 13, 2020
- FDA report date
- Aug 12, 2020
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Yusef Manufacturing Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-1486-2020, exactly as published.
Show all FDA fields
- City
- Clearfield
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 86007
- Address
- Freeport West, F-4, #3
- Code information
- Lot #: 12750, Exp 5/2021
- Postal code
- 84016
- Report date
- Aug 12, 2020
- Product type
- Drugs
- Recall number
- D-1486-2020
- Classification
- Class II
- Recalling firm
- Yusef Manufacturing Laboratories, LLC
- Termination date
- Feb 13, 2024
- Reason for recall
- Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 13, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2020