Why it was recalled
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.
Product description
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
Lot numbers, UPCs & expiration codes
Lot 022110-01
Where it was sold
Maine
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-1380-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 20, 2012
- FDA report date
- Jun 20, 2012
- Quantity
- 4800 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Quadrant Chemical Corporation
Original FDA data
Every field from FDA enforcement report D-1380-2012, exactly as published.
Show all FDA fields
- City
- Garland
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 61518
- Address
- 3309 W Kingsley Rd
- Code information
- Lot 022110-01
- Postal code
- 75041-2207
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1380-2012
- Classification
- Class III
- Recalling firm
- Quadrant Chemical Corporation
- Product quantity
- 4800 bottles
- Termination date
- Sep 13, 2012
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
- Distribution pattern
- Maine
- Recall initiation date
- Mar 20, 2012
- Initial firm notification
- Center classification date
- Jun 14, 2012