Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83413

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

Open FDA event record

Event summary

Timeline bucket
July 23, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Glenmark Pharmaceuticals Inc., USA

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

Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

D-1586-2019
Recall number
D-1586-2019
Initiated
July 23, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.

Code information

a) 05171238, 05171248, 05171249, Exp. Jul-2019; 05171582, 05171612, Exp. Aug-2019; 05171674, 05171675, 05171682, Exp. Sep 2019; 05180065, 05180066, Exp. Dec 2019; 05180264, 05180264, 05180265, 05180275, 0518276, Exp. Jan 2020; 05180411, 05180412, 05180422, Exp. Jan 2020; 05180556, 05180568 Exp..Feb-2020; 05180889, 05180890, 05180896, 05180896, 05180897 Exp. Apr 2020; 05181123, 05181129, 05181134, 05181135, Exp. May 2020; 05181415, 05181425, 05181429, 05181433, Exp. Jun 2020; 05181528, Exp. Jul 2020; 05181747, 05181748, Exp. Aug 2020. b) 05171207, 05171212, 05171213, 05171232, 05171233, Exp. Jul-2019; 05171476, 05171478, 05171479, Exp. Aug 2019; 05171596 , 05171597, 05171602, 05171603, Exp. Aug 2019; 05171683, 05171697, 05171698, 05171703, 05171718, 05171783, 05171788, 05171789, 05171790, 05171791, Exp. Sep 2019; 05180092, 05180093, 05180119, 05180219, 05180220, Exp. Dec 2019; 05180289, 05180291, 05180434,05180435, Exp. Jan-2020; 05180438, 05180439, 05180443, 05180444, 05180450, 05180462, 05180572, 05180646, Exp. Feb 2020 05180648, 05180649, 05180659, 05180660, 05180671, Mar 2020; 05180870, 05180871, 05180874, 05180877, 05180900, 05180901, Exp. Apr 2020; 05181073, 05181074, 05181086, 05181087, 05181091, 05181092, 05181101, 05181102, 05181111, 05181146, 05181147, 05181148, 05181240 Exp. May 2020; 05181241, 05181248, 05181252, 05181253, 05181257, 05181265, 05181266, 05181267, 05181272, 05181309, 05181316, 05181317, 05181332 Exp. Jun 2020; 05181588, 05181602, 05181603, 05181618, 05181619, 05181621, 05181622, 05181633, 05181634 Exp. Jul 2020; 05181754, 05181772, 05181773, 05181781 Exp. Aug 2020

Distribution pattern

Nationwide within the United States