Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89415

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

Open FDA event record

Event summary

Timeline bucket
January 21, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan 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

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

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.

D-0452-2022
Recall number
D-0452-2022
Initiated
January 21, 2022
Classification
Class II
Status
Terminated
Recalling firm
Mylan Pharmaceuticals Inc
Quantity
233,199/10 g aerosol containers

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deficiencies

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deficiencies

Code information

Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023

Distribution pattern

Recalled product was distributed nationwide within the United States.