D-1380-2012 Class III Terminated
FDA drug recall D-1380-2012 was initiated by Quadrant Chemical Corporation on March 20, 2012 and is designated Class III. 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. The recall status is terminated (terminated September 13, 2012). Affected quantity: 4800 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2012
- Initiation Date
- March 20, 2012
- Termination Date
- September 13, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4800 bottles
Product Description
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
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.
Distribution Pattern
Maine
Code Information
Lot 022110-01