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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73419

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

Open FDA event record

Event summary

Timeline bucket
January 26, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Apotex Scientific, 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

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

D-1435-2016
Recall number
D-1435-2016
Initiated
January 26, 2016
Classification
Class III
Status
Terminated
Recalling firm
Apotex Scientific, Inc
Quantity
107,880 (60 ct bottle)

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 Dissolution Specification: Out of specification dissolution results when testing product stability.

Code information

Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.

Distribution pattern

Nationwide, Alaska, Hawaii, and Puerto Rico.

drug · product 2 of 3

Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;

D-1436-2016
Recall number
D-1436-2016
Initiated
January 26, 2016
Classification
Class III
Status
Terminated
Recalling firm
Apotex Scientific, Inc
Quantity
605,989 (30 ct) 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 Dissolution Specification: Out of specification dissolution results when testing product stability.

Code information

Lot #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016; Lot #: KY9961, Exp 04/30/2016; Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016.

Distribution pattern

Nationwide, Alaska, Hawaii, and Puerto Rico.

drug · product 3 of 3

Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.

D-1437-2016
Recall number
D-1437-2016
Initiated
January 26, 2016
Classification
Class III
Status
Terminated
Recalling firm
Apotex Scientific, Inc
Quantity
750,273 (30 ct) 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 Dissolution Specification: Out of specification dissolution results when testing product stability.

Code information

Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016.

Distribution pattern

Nationwide, Alaska, Hawaii, and Puerto Rico.