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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76233

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

Open FDA event record

Event summary

Timeline bucket
December 07, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Novum Pharma, 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

Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654

D-0433-2017
Recall number
D-0433-2017
Initiated
December 07, 2016
Classification
Class III
Status
Terminated
Recalling firm
Novum Pharma, LLC
Quantity
6,763 1 gram sample packets

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: Out of specification result for pramoxine hydrochloride

Code information

Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18

Distribution pattern

Nationwide