D-0634-2020 Class III Terminated
FDA drug recall D-0634-2020 was initiated by Island Kinetics, Inc. d.b.a. CoValence Laboratories on December 20, 2019 and is designated Class III. Reason for recall: Superpotent Drug: Salicylic acid content is above the firm's specification. The recall status is terminated (terminated August 25, 2021). Affected quantity: 2542 units.
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2020
- Initiation Date
- December 20, 2019
- Termination Date
- August 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2542 units
Product Description
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.
Reason for Recall
Superpotent Drug: Salicylic acid content is above the firm's specification.
Distribution Pattern
AZ
Code Information
Batch number: L041918A, Exp. 04/2021 Lot # F9518B2