Why it was recalled
Superpotent Drug: Salicylic acid content is above the firm's specification.
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.
Lot numbers, UPCs & expiration codes
Batch number: L041918A, Exp. 04/2021 Lot # F9518B2
Where it was sold
AZ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0634-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 20, 2019
- FDA report date
- Jan 8, 2020
- Quantity
- 2542 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Island Kinetics, Inc. d.b.a. CoValence Laboratories
Original FDA data
Every field from FDA enforcement report D-0634-2020, exactly as published.
Show all FDA fields
- City
- Chandler
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 84561
- Address
- 460 S Benson Ln Ste 1-3
- Code information
- Batch number: L041918A, Exp. 04/2021 Lot # F9518B2
- Postal code
- 85224-5663
- Report date
- Jan 8, 2020
- Product type
- Drugs
- Recall number
- D-0634-2020
- Classification
- Class III
- Recalling firm
- Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Product quantity
- 2542 units
- Termination date
- Aug 25, 2021
- Reason for recall
- Superpotent Drug: Salicylic acid content is above the firm's specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- AZ
- Recall initiation date
- Dec 20, 2019
- Initial firm notification
- Telephone
- Center classification date
- Dec 31, 2019