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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94466

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

Open FDA event record

Event summary

Timeline bucket
April 25, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
FDC Limited

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

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ

D-0488-2024
Recall number
D-0488-2024
Initiated
April 25, 2024
Classification
Class II
Status
Terminated
Recalling firm
FDC Limited
Quantity
382,104 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

Code information

Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.

Distribution pattern

New Jersey Only