Exact FDA event identifier

Event 79604

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

Event summary

Timeline bucket: March 21, 2018
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Mayne Pharma 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

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

D-0616-2018

Recall number: D-0616-2018
Initiated: March 21, 2018
Classification: Class III
Status: Terminated
Recalling firm: Mayne Pharma Inc
Quantity: 3312 cans

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.

Code information

Lot: MBEB, Exp. 01/31/2019

Distribution pattern

Nationwide in the USA