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Recall Observatory FDA recall evidence

Drug 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

D-1299-2022

June 29, 2022

Class III

Product summary

Firm
Eco Lips, Inc
Event
Event 90560
Status
Terminated
Classification
Class III
Quantity
35,313 tubes
Official record key
drug-enforcement:D-1299-2022

Official wording

Reason: Failed Dissolution Specifications

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

Distribution pattern: CA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications