Why it was recalled
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 070421E211; 070921E221; 071021E231; 071021E241, Exp 7/2021
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1337-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 3, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- 82,800 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A.P. Deauville, LLC
Original FDA data
Every field from FDA enforcement report D-1337-2020, exactly as published.
Show all FDA fields
- City
- New Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85806
- Address
- 594 Jersey Ave Unit C
- Code information
- Lot #: 070421E211; 070921E221; 071021E231; 071021E241, Exp 7/2021
- Postal code
- 08901-3502
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1337-2020
- Classification
- Class II
- Recalling firm
- A.P. Deauville, LLC
- Product quantity
- 82,800 bottles
- Termination date
- Oct 26, 2021
- Reason for recall
- cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jun 3, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2020