Exact FDA event identifier

Event 65515

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

Event summary

Timeline bucket: June 18, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals USA, 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

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

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

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01

D-847-2013

Recall number: D-847-2013
Initiated: June 18, 2013
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 16,293 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 Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Code information

34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.

Distribution pattern

Nationwide

drug · product 2 of 3

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01

D-848-2013

Recall number: D-848-2013
Initiated: June 18, 2013
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 13,478 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 Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Code information

34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.

Distribution pattern

Nationwide

drug · product 3 of 3

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01

D-849-2013

Recall number: D-849-2013
Initiated: June 18, 2013
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 7,579 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 Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Code information

34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.

Distribution pattern

Nationwide