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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93719

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

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Event summary

Timeline bucket
January 04, 2024
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

Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56

D-0259-2024
Recall number
D-0259-2024
Initiated
January 04, 2024
Classification
Class II
Status
Terminated
Quantity
38,496 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Code information

Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024

Distribution pattern

USA Nationwide

Field note

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