Exact FDA event identifier

Event 85806

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 03, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: A.P. Deauville, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

Recall number: D-1337-2020
Initiated: June 03, 2020
Classification: Class II
Status: Terminated
Recalling firm: A.P. Deauville, LLC
Quantity: 82,800 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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