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
Product summary
- 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
Labeling: Label Mix-Up