D-1486-2020 Class II Terminated

Recalled by Yusef Manufacturing Laboratories, LLC — Clearfield, UT

FDA drug recall D-1486-2020 was initiated by Yusef Manufacturing Laboratories, LLC on June 13, 2020 and is designated Class II. Reason for recall: Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate. The recall status is terminated (terminated February 13, 2024).

Recall Details

Product Type
Drugs
Report Date
August 12, 2020
Initiation Date
June 13, 2020
Termination Date
February 13, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

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

Reason for Recall

Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.

Distribution Pattern

USA Nationwide

Code Information

Lot #: 12750, Exp 5/2021