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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84282

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

Open FDA event record

Event summary

Timeline bucket
November 15, 2019
Product types
Drug
Classifications
Class III
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

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

Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430

D-0618-2020
Recall number
D-0618-2020
Initiated
November 15, 2019
Classification
Class III
Status
Terminated
Quantity
a) 34521 bottles; b) 16930 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective delivery system; product is not foaming or is coming out as liquid.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective delivery system; product is not foaming or is coming out as liquid.

Code information

a) 14190026, 14190028, 14190029, exp Feb-2021, 14190043, 14190045 exp Apr-2021 b) 14190024, 14190025, 14190027, exp Feb-2021, 14190030, 14190031, exp Mar-2021, 14190039, 14190042 exp Apr-2021, 14190047 exp May-2021, 14190062 exp Jul-2021

Distribution pattern

Nationwide

drug · product 2 of 2

Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

D-0619-2020
Recall number
D-0619-2020
Initiated
November 15, 2019
Classification
Class III
Status
Terminated
Quantity
a) 480 packs; b) 240 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective delivery system; product is not foaming or is coming out as liquid.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective delivery system; product is not foaming or is coming out as liquid.

Code information

Lot 14190067, exp Jul-2021

Distribution pattern

Nationwide