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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67053

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

Open FDA event record

Event summary

Timeline bucket
November 06, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Actavis Elizabeth 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

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

Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)

D-1087-2014
Recall number
D-1087-2014
Initiated
November 06, 2013
Classification
Class II
Status
Terminated
Recalling firm
Actavis Elizabeth LLC
Quantity
13,608 bottles

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: During routine stability testing one tablet was found with tablet weight below specification.

Code information

lot 58468552 Exp. 05/15

Distribution pattern

Nationwide