Why it was recalled
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Product description
Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
Lot numbers, UPCs & expiration codes
Lot #: 087293, Exp. Date 06/30/2020; 091356, Exp. Date 03/31/2021; Lot #: 093770, 093771, Exp. Date 07/31/2021
Where it was sold
Nationwide within the United States
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-1409-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 6, 2020
- FDA report date
- Aug 5, 2020
- Quantity
- 4,018 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan PLC
Original FDA data
Every field from FDA enforcement report D-1409-2020, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 85924
- Address
- 2525 Dupont Dr
- Code information
- Lot #: 087293, Exp. Date 06/30/2020; 091356, Exp. Date 03/31/2021; Lot #: 093770, 093771, Exp. Date 07/31/2021
- Postal code
- 92612-1531
- Report date
- Aug 5, 2020
- Product type
- Drugs
- Recall number
- D-1409-2020
- Classification
- Class III
- Recalling firm
- Allergan PLC
- Product quantity
- 4,018 bottles
- Termination date
- Feb 28, 2024
- Reason for recall
- SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 6, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 27, 2020