Soft Whisper Dandruff Shampoo Recalled for Water Quality Deviations
A.P. Deauville, LLC is recalling Soft Whisper Dandruff Shampoo because it was produced with water that failed USP specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
A.P. Deauville, LLC is recalling 82,800 bottles of Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL). The product is identified by NDC 42913-020-00 and UPC 815195014097. The affected lots are 070421E211, 070921E221, 071021E231, and 071021E241, all with an expiration date of 7/2021.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the shampoo was produced with water that failed United States Pharmacopeia (USP) specifications. The product was distributed nationwide in the United States.
Consumers who have this product should stop using it and contact A.P. Deauville, LLC for further instructions.
The recalled product
- 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
- Manufacturer
- A.P. Deauville, LLC
- Category
- Drug — Shampoo
- Affected units
- 82,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: 070421E211
- 070921E221
- 071021E231
- 071021E241
- Exp 7/2021
Distribution
Distributed nationwide across the United States.
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