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Class II: temporary or reversible health riskTerminated

Yusef Manufacturing Laboratories Tropical Lip Moisturizer Recall

Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzon…

Yusef Manufacturing Laboratories, LLC · Clearfield, UT

Risk level
Class II
Reported by FDA
Aug 12, 2020
Recall ID
D-1486-2020
Check your lot numberHow we source this data

Summary

Yusef Manufacturing Laboratories recalled Tropical Lip Moisturizer starting Jun 13, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1486-2020 on Aug 12, 2020. Reason: Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1486-2020, published Aug 12, 2020. 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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