Drug 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
D-1337-2020
Product summary
- Event
- Event 85806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82,800 bottles
- Official record key
drug-enforcement:D-1337-2020
Official wording
Reason: cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Code information: Lot #: 070421E211; 070921E221; 071021E231; 071021E241, Exp 7/2021
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations