Exact FDA event identifier

Event 87608

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

Event summary

Timeline bucket: March 25, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cosette 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

D-0327-2021

Recall number: D-0327-2021
Initiated: March 25, 2021
Classification: Class II
Status: Terminated
Recalling firm: Cosette Pharmaceuticals, Inc.
Quantity: a) 30 mL: 7724 b) 60 mL: 8064 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

CGMP Deviaitons

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviaitons

Code information

a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022

Distribution pattern

Nationwide in the US