Recalls / Class II
Class IID-1337-2020
Product
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 lot / code info
- Lot #: 070421E211; 070921E221; 071021E231; 071021E241, Exp 7/2021
Why it was recalled
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Recalling firm
- Firm
- A.P. Deauville, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 594 Jersey Ave Unit C, N/A, New Brunswick, New Jersey 08901-3502
Distribution
- Quantity
- 82,800 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-06-03
- FDA classified
- 2020-06-24
- Posted by FDA
- 2020-07-01
- Terminated
- 2021-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1337-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.