June 2020 FDA Recall Drug by Yusef Manufacturing Laboratories, Llc
D-1540-2020 - Superpotent Drug

This Class II drug recall was voluntarily initiated by Yusef Manufacturing Laboratories, Llc on June 3, 2020 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed in Shipped to one distributer located in Colorado and the recall is currently terminated.

Recall Number: D-1540-2020

Reason for Recall
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Initiated
06-03-2020
Reported
09-02-2020
Quantity
2,558 pieces

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85814
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Yusef Manufacturing Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Shipped to one distributer located in Colorado
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-13-2024
Product Description About Product Description
Full technical description of the product.
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3

Batch or Lot Expiration Information

Batch# Part ID 9PRKY01
Batch# 13852