Recalls / Class III
Class IIID-1409-2020
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
- Affected lot / code info
- Lot #: 087293, Exp. Date 06/30/2020; 091356, Exp. Date 03/31/2021; Lot #: 093770, 093771, Exp. Date 07/31/2021
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
- 4,018 bottles
- 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-1409-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.