Exact FDA event identifier

Event 69359

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

Event summary

Timeline bucket: October 02, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Valeant Pharmaceuticals International

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

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

Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15

D-0025-2015

Recall number: D-0025-2015
Initiated: October 02, 2014
Classification: Class III
Status: Terminated
Recalling firm: Valeant Pharmaceuticals International
Quantity: 34,218 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

Code information

Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 2

Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15

D-0026-2015

Recall number: D-0026-2015
Initiated: October 02, 2014
Classification: Class III
Status: Terminated
Recalling firm: Valeant Pharmaceuticals International
Quantity: 1663 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

Code information

Lot number 13052B, Exp. 03/2015, NDC16781-382-15

Distribution pattern

Nationwide and Puerto Rico