Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
DermaZinc Spray
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
Drug: Zinc
- Recalling firm
- Quadrant Chemical Corporation
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1380-2012 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Zinc recalls
See all
Class II · Moderate risk
Rohto Cooling Eye Drops ALL-IN-ONE
Lack of Assurance of Sterility
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Other wrong potency / content recalls from 2012
All wrong potency / content recalls
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I · High risk
Hydrocodone bitartrate and acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class III · Low risk
Clean & Clear advantage
Superpotent (Single Ingredient Drug): salicylic acid
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