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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76011

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

Open FDA event record

Event summary

Timeline bucket
December 06, 2016
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Cipher Pharmaceuticals US LLC

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

INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01

D-0237-2017
Recall number
D-0237-2017
Initiated
December 06, 2016
Classification
Class III
Status
Ongoing
Quantity
216 boxes

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: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

Code information

Lot #01316L02 6871201301

Distribution pattern

AZ, CO and OH.