Drug product
PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.
D-0634-2020
Product summary
- Event
- Event 84561
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2542 units
- Official record key
drug-enforcement:D-0634-2020
Official wording
Reason: Superpotent Drug: Salicylic acid content is above the firm's specification.
Code information: Batch number: L041918A, Exp. 04/2021 Lot # F9518B2
Distribution pattern: AZ
Derived failure modes
-
Potency or specification failure
Superpotent