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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63685

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

Open FDA event record

Event summary

Timeline bucket
November 21, 2012
Product types
Drug
Classifications
Class II
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

Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.

D-086-2013
Recall number
D-086-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
39,982 Tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

Code information

Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.

Distribution pattern

Nationwide and Puerto Rico