Why it was recalled
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Product description
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
Lot numbers, UPCs & expiration codes
Lot #: 090645A, 090645B, Exp. Date 07/31/2020; 090645C, Exp. Date 08/31/2020; Lot #: 090757A, Exp. Date 02/29/2020; Lot # 093199A, 093199B, 093199C, 093199D, Exp. Date 12/31/2020; Lot #: 096375A, 096375B, Exp. Date 06/30/2021; Lot #: 097455A, 097612A, Exp. Date 04/30/2021
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-1410-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 6, 2020
- FDA report date
- Aug 5, 2020
- Quantity
- 8,555 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan PLC
Original FDA data
Every field from FDA enforcement report D-1410-2020, 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 #: 090645A, 090645B, Exp. Date 07/31/2020; 090645C, Exp. Date 08/31/2020; Lot #: 090757A, Exp. Date 02/29/2020; Lot # 093199A, 093199B, 093199C, 093199D, Exp. Date 12/31/2020; Lot #: 096375A, 096375B, Exp. Date 06/30/2021; Lot #: 097455A, 097612A, Exp. Date 04/30/2021
- Postal code
- 92612-1531
- Report date
- Aug 5, 2020
- Product type
- Drugs
- Recall number
- D-1410-2020
- Classification
- Class III
- Recalling firm
- Allergan PLC
- Product quantity
- 8,555 kits
- 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 System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 6, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 27, 2020