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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88755

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

Open FDA event record

Event summary

Timeline bucket
September 23, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Monarch PCM, 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

Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01

D-0855-2021
Recall number
D-0855-2021
Initiated
September 23, 2021
Classification
Class II
Status
Terminated
Recalling firm
Monarch PCM, LLC
Quantity
11,419 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Finished product specification did not meet USP specifications.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Finished product specification did not meet USP specifications.

Code information

Lots: 21FP1743, 21FP1745 Exp. 05/2023

Distribution pattern

TN