Status
Terminated
Drug Enforcement D-1380-2012
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.
Classification
Class III
Report Date
June 20, 2012
Termination Date
September 13, 2012
Product Information
- Product description
- DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
- Product quantity
- 4800 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Maine
Location & Firm
- Recalling firm
- Quadrant Chemical Corporation
- Address
-
3309 W Kingsley Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1380-2012
- Event ID
- 61518
- Recall initiation date
- March 20, 2012
- Center classification date
- June 14, 2012
- Code info
- Lot 022110-01
- More code info
- —