Exact FDA event identifier

Event 68453

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 16, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Actavis 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

1 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 1

Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.

D-1386-2014

Recall number: D-1386-2014
Initiated: May 16, 2014
Classification: Class II
Status: Terminated
Recalling firm: Actavis Inc
Quantity: 6913 packages

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 #: 3100135, Expiry: 05/2014

Distribution pattern

U.S. Nationwide