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Class III: unlikely to cause harmTerminated

Quadrant Chemical DermaZinc Spray Recall

DermaZinc Spray, 0

Quadrant Chemical Corporation · Garland, TX

Risk level
Class III
Reported by FDA
Jun 20, 2012
Recall ID
D-1380-2012
Check your lot numberHow we source this data

Summary

Quadrant Chemical recalled DermaZinc Spray starting Mar 20, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1380-2012 on Jun 20, 2012. 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. Status: Terminated.

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
E-Mail
Center classification date
Jun 14, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1380-2012, published Jun 20, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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