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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78157

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

Open FDA event record

Event summary

Timeline bucket
September 20, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Taro Pharmaceuticals U.S.A., 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

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

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1

D-0146-2018
Recall number
D-0146-2018
Initiated
September 20, 2017
Classification
Class III
Status
Terminated
Quantity
16,944 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination with other products: traces of Dapsone were found in the finished product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products: traces of Dapsone were found in the finished product.

Code information

Lot #: A771026850, Exp 6/18

Distribution pattern

Nationwide