Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68683

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 03, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Fougera Pharmaceuticals 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

2 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 2

Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.

D-1440-2014
Recall number
D-1440-2014
Initiated
July 03, 2014
Classification
Class III
Status
Terminated
Quantity
111,388 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Code information

Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.

Distribution pattern

Nationwide

drug · product 2 of 2

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.

D-1441-2014
Recall number
D-1441-2014
Initiated
July 03, 2014
Classification
Class III
Status
Terminated
Quantity
3,594 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
may not meet specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Code information

Lot: 849R, Exp 04/2015

Distribution pattern

Nationwide