Drug product
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
D-1076-2018
Product summary
- Event
- Event 80753
- Status
- Terminated
- Classification
- Class III
- Quantity
- 75,000 pads
- Official record key
drug-enforcement:D-1076-2018
Official wording
Reason: Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Code information: Lot # 2458067, Exp 11/2019
Distribution pattern: Product was distributed to one distributor in VA
Derived failure modes
-
Potency or specification failure
Subpotent