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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69553

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

Open FDA event record

Event summary

Timeline bucket
August 25, 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

Complete imported group

Every recalled product in this event

2 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 2

Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4

D-0232-2015
Recall number
D-0232-2015
Initiated
August 25, 2014
Classification
Class II
Status
Terminated
Recalling firm
Actavis Inc
Quantity
26,663 cartons

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

3103681, exp Aug 2014, 3104886, exp Oct 2014, 3105836, exp Dec 2014, and 3106650, exp Dec 2014

Distribution pattern

Nationwide

drug · product 2 of 2

Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1

D-0233-2015
Recall number
D-0233-2015
Initiated
August 25, 2014
Classification
Class II
Status
Terminated
Recalling firm
Actavis Inc
Quantity
46,676 cartons

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

3101178, exp Aug 2014, 3104318, exp Aug 2014, 3104319, exp Oct 2014, 3104889, exp Oct 2014, 3104891, exp Oct 2014, 3104893, exp Oct 2014, and 3106651, exp Dec 2014

Distribution pattern

Nationwide