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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63926

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

Open FDA event record

Event summary

Timeline bucket
December 04, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amedra Pharmaceuticals 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

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09

D-171-2013
Recall number
D-171-2013
Initiated
December 04, 2012
Classification
Class II
Status
Terminated
Quantity
1,176 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: The affected lots may not meet the specifications for dissolution over the product shelf life.

Code information

Lot 238316, exp 01/31/2014

Distribution pattern

Nationwide and Puerto Rico.

drug · product 2 of 3

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09

D-172-2013
Recall number
D-172-2013
Initiated
December 04, 2012
Classification
Class II
Status
Terminated
Quantity
12,948 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: The affected lots may not meet the specifications for dissolution over the product shelf life.

Code information

Lot 220839, exp 11/30/2013

Distribution pattern

Nationwide and Puerto Rico.

drug · product 3 of 3

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09

D-173-2013
Recall number
D-173-2013
Initiated
December 04, 2012
Classification
Class II
Status
Terminated
Quantity
10,968 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: The affected lots may not meet the specifications for dissolution over the product shelf life.

Code information

Lot 220843, exp 11/30/2013

Distribution pattern

Nationwide and Puerto Rico.