Drug 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
D-1410-2020
Product summary
- Firm
- Allergan PLC
- Event
- Event 85924
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,555 kits
- Official record key
drug-enforcement:D-1410-2020
Official wording
Reason: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
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
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
SUBPOTENT