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Recall Observatory FDA recall evidence

Drug product

Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426

D-0257-2021

January 06, 2021

Class II

Product summary

Firm
DLC Laboratories, Inc
Event
Event 87257
Status
Terminated
Classification
Class II
Quantity
86,297 jars
Official record key
drug-enforcement:D-0257-2021

Official wording

Reason: Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.

Code information: Lot # 5084, Exp 05/23; 5130, Exp 07/23; 5132, Exp 07/23; 5160, Exp 08/23.

Distribution pattern: Distributed Nationwide and to the following foreign countries: Canada, Cambodia, Germany, and United Kingdom.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up