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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88598

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

Open FDA event record

Event summary

Timeline bucket
September 01, 2021
Product types
Drug
Classifications
Class III
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

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

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

D-0817-2021
Recall number
D-0817-2021
Initiated
September 01, 2021
Classification
Class III
Status
Terminated
Recalling firm
Monarch PCM, LLC
Quantity
a) 3305 bottles; b) 840 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotency: one product for active ingredient assay and another one for preservative assay

Code information

Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023

Distribution pattern

OH, TN

drug · product 2 of 2

Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5

D-0818-2021
Recall number
D-0818-2021
Initiated
September 01, 2021
Classification
Class III
Status
Terminated
Recalling firm
Monarch PCM, LLC
Quantity
6305 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotency: one product for active ingredient assay and another one for preservative assay

Code information

Lot: 21FP1731 Exp 05/2023

Distribution pattern

OH, TN