Exact FDA event identifier

Event 77105

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

Event summary

Timeline bucket: December 27, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: The Harvard Drug Group

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04

D-0692-2017

Recall number: D-0692-2017
Initiated: December 27, 2016
Classification: Class III
Status: Terminated
Recalling firm: The Harvard Drug Group
Quantity: 36,990 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug; out of specification results for assay (manufacturer)

Code information

LOT: T-00601 Exp: 04-2017

Distribution pattern

Nationwide and PR