Drug product
CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01
D-0673-2017
Product summary
- Event
- Event 76743
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,647 units
- Official record key
drug-enforcement:D-0673-2017
Official wording
Reason: Discoloration.
Code information: Lot #: a) 15I1234, Exp. 09/18, b) 15E1221, Exp. 09/18, c) 15G1235 and 15I1236, Exp. 09/18.
Distribution pattern: nationwide
Derived failure modes
-
Unknown
Discoloration.