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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90569

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

Open FDA event record

Event summary

Timeline bucket
July 07, 2022
Product types
Drug
Classifications
Class II
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

Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

D-1285-2022
Recall number
D-1285-2022
Initiated
July 07, 2022
Classification
Class II
Status
Terminated
Recalling firm
Apotex Corp.
Quantity
2010 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed dissolution specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

Code information

Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023

Distribution pattern

USA Nationwide