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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68729

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

Open FDA event record

Event summary

Timeline bucket
July 17, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
X-Gen Pharmaceuticals 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

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

Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.

D-1444-2014
Recall number
D-1444-2014
Initiated
July 17, 2014
Classification
Class III
Status
Terminated
Quantity
8,356 vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".

Code information

Lot: PLNB1412, Exp 12/15

Distribution pattern

Nationwide