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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91353

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

Open FDA event record

Event summary

Timeline bucket
December 21, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Apotex Corp.

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%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4

D-0093-2023
Recall number
D-0093-2023
Initiated
December 21, 2022
Classification
Class III
Status
Terminated
Recalling firm
Apotex Corp.
Quantity
22,027 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

Code information

Lot# TA4844, Exp 03/2023

Distribution pattern

USA Nationwide