Drug product
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
D-1380-2012
Product summary
- Event
- Event 61518
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4800 bottles
- Official record key
drug-enforcement:D-1380-2012
Official wording
Reason: Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
Code information: Lot 022110-01
Distribution pattern: Maine
Derived failure modes
-
Potency or specification failure
Subpotent