Exact FDA event identifier

Event 73895

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

Event summary

Timeline bucket: April 04, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Keystone Laboratories Inc

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

BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.

D-0853-2016

Recall number: D-0853-2016
Initiated: April 04, 2016
Classification: Class II
Status: Terminated
Recalling firm: Keystone Laboratories Inc
Quantity: 7 Cases of 12 Bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products: Failed S.aureus test.

Code information

Lot #: 10AN5

Distribution pattern

U.S. Including: MD and NJ