Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Soft Whisper by Powerstick Dandruff Shampoo
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097
Affected NDC
42913-0020-00
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
- Recalling firm
- A.P. Deauville, LLC
- NDC code
- 42913-020-00
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1337-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
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