Drug product
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
D-1409-2020
Product summary
- Firm
- Allergan PLC
- Event
- Event 85924
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,018 bottles
- Official record key
drug-enforcement:D-1409-2020
Official wording
Reason: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Code information: Lot #: 087293, Exp. Date 06/30/2020; 091356, Exp. Date 03/31/2021; Lot #: 093770, 093771, Exp. Date 07/31/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
SUBPOTENT