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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71046

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 07, 2015
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Apotex Inc.

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

3 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 3

Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

D-1079-2015
Recall number
D-1079-2015
Initiated
April 07, 2015
Classification
Class III
Status
Terminated
Recalling firm
Apotex Inc.
Quantity
23,274 bottles/ blister cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot #: a) KL0655, Exp 04/15; KY2374, Exp 05/16; b) KL0656, Exp 04/15; KY2371, Exp 05/16

Distribution pattern

Nationwide

drug · product 2 of 3

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

D-1080-2015
Recall number
D-1080-2015
Initiated
April 07, 2015
Classification
Class III
Status
Terminated
Recalling firm
Apotex Inc.
Quantity
6,467 bottles/ blister cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16

Distribution pattern

Nationwide

drug · product 3 of 3

Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

D-1081-2015
Recall number
D-1081-2015
Initiated
April 07, 2015
Classification
Class III
Status
Terminated
Recalling firm
Apotex Inc.
Quantity
5,352 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot # KL0664, Exp 04/15

Distribution pattern

Nationwide