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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69445

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

Open FDA event record

Event summary

Timeline bucket
June 05, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Valeant Pharmaceuticals North America LLC

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

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.

D-0051-2015
Recall number
D-0051-2015
Initiated
June 05, 2014
Classification
Class III
Status
Terminated
Quantity
20,499 HDPE bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert

Code information

Lot # 13E019P; Exp 03/17

Distribution pattern

Nationwide

drug · product 2 of 3

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7

D-0052-2015
Recall number
D-0052-2015
Initiated
June 05, 2014
Classification
Class III
Status
Terminated
Quantity
23,057 HDPE bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert

Code information

Lot #: a) 13E020P; Exp. 03/17 Lot #: b) 13E029P, 13E028P, 13K032P; Exp. 03/17

Distribution pattern

Nationwide

drug · product 3 of 3

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7

D-0053-2015
Recall number
D-0053-2015
Initiated
June 05, 2014
Classification
Class III
Status
Terminated
Quantity
55,650 HDPE bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Package Insert

Code information

Lot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073P; Exp. 09/15 13A036P; Exp. 11/15 13B035P; Exp. 11/15 13C046P; Exp. 11/15 13D060P; Exp. 11/15 13E030P; Exp. 03/16 13E031P; Exp. 03/16 13F003P; Exp. 03/16 13K034P; Exp. 03/16 14A001P; Exp. 10/16

Distribution pattern

Nationwide