Recalls / Class III
Class IIID-1410-2020
Product
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
- Affected lot / code info
- 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
Why it was recalled
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Recalling firm
- Firm
- Allergan PLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 Dupont Dr, N/A, Irvine, California 92612-1531
Distribution
- Quantity
- 8,555 kits
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-07-06
- FDA classified
- 2020-07-27
- Posted by FDA
- 2020-08-05
- Terminated
- 2024-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1410-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.