Why it was recalled
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Product description
Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
Lot numbers, UPCs & expiration codes
Lot # 2458067, Exp 11/2019
Where it was sold
Product was distributed to one distributor in VA
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-1076-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Aug 22, 2018
- Quantity
- 75,000 pads
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Huijing (Shanghai) Bio-tech Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-1076-2018, exactly as published.
Show all FDA fields
- City
- Shanghai
- Status
- Terminated
- Country
- China
- Event ID
- 80753
- Address
- No 811 Gaofeng Rd.
- Code information
- Lot # 2458067, Exp 11/2019
- Report date
- Aug 22, 2018
- Product type
- Drugs
- Recall number
- D-1076-2018
- Classification
- Class III
- Recalling firm
- Huijing (Shanghai) Bio-tech Co., Ltd.
- Product quantity
- 75,000 pads
- Termination date
- Dec 19, 2018
- Reason for recall
- Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
- Distribution pattern
- Product was distributed to one distributor in VA
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2018