Multi-event June 2022 FDA Recall Drug by Eco Lips, Inc

This Multi-event Class III drug recall was voluntarily initiated by Eco Lips, Inc on June 29, 2022 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in CA and the recall is currently terminated.

Reported Recall Events

D-1299-2022 TERMINATED D-1298-2022 TERMINATED

Recall Number: D-1299-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
06-29-2022
Reported
08-03-2022
Quantity
35,313 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90560
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eco Lips, Inc
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2024
Product Description About Product Description
Full technical description of the product.
Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Batch or Lot Expiration Information

Lot# : 90122-21015, Exp: 01/24
Lot# : 90122-20356, Exp: 12/23

Recall Number: D-1298-2022

Reason for Recall
Failed Dissolution Specifications
Initiated
06-29-2022
Reported
08-03-2022
Quantity
15,313 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90560
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eco Lips, Inc
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2024
Product Description About Product Description
Full technical description of the product.
Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Batch or Lot Expiration Information

Lot# : 90121-20321 Exp: 11/2023