Why it was recalled
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 5084, Exp 05/23; 5130, Exp 07/23; 5132, Exp 07/23; 5160, Exp 08/23.
Where it was sold
Distributed Nationwide and to the following foreign countries: Canada, Cambodia, Germany, and United Kingdom.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0257-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 6, 2021
- FDA report date
- Feb 24, 2021
- Quantity
- 86,297 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DLC Laboratories, Inc
Original FDA data
Every field from FDA enforcement report D-0257-2021, exactly as published.
Show all FDA fields
- City
- Paramount
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 87257
- Address
- 7008 Marcelle St
- Code information
- Lot # 5084, Exp 05/23; 5130, Exp 07/23; 5132, Exp 07/23; 5160, Exp 08/23.
- Postal code
- 90723-4839
- Report date
- Feb 24, 2021
- Product type
- Drugs
- Recall number
- D-0257-2021
- Classification
- Class II
- Recalling firm
- DLC Laboratories, Inc
- Product quantity
- 86,297 jars
- Termination date
- Sep 23, 2022
- Reason for recall
- Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide and to the following foreign countries: Canada, Cambodia, Germany, and United Kingdom.
- Recall initiation date
- Jan 6, 2021
- Initial firm notification
- Center classification date
- Feb 12, 2021