CLASS III Drug recall · Reported 20 Jun 2012 · FDA Enforcement Report
DermaZinc Spray, 0.25% zinc pyritione, topical recalled
Quadrant Chemical is recalling DermaZinc Spray, 0.25% zinc pyritione, topical, distributed in Maine. The recall was initiated on 20 Mar 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1380-2012
- FDA event ID
- 61518
- Recalling firm
- Quadrant Chemical, Garland, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Mar 2012
- FDA classified
- 14 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 20 Mar 2012 | Recall initiated by company | |
| 14 Jun 2012 | Classified by FDA | +86 days |
| 20 Jun 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
Where it was distributed
Maine
Questions about this recall
Why was it 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.
Which lots are affected?
Lot 022110-01
Where was it sold?
Maine
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.