Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13…
Reason Lack of Assurance of Sterility
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P…
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.
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
- 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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Ongoing
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Class II · Moderate risk Ongoing
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Reason CGMP Deviations; deficiencies observed during FDA inspection
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