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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67903

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

Open FDA event record

Event summary

Timeline bucket
March 26, 2014
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Pharmakon Pharmaceuticals

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

Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.

D-1362-2014
Recall number
D-1362-2014
Initiated
March 26, 2014
Classification
Class I
Status
Terminated
Recalling firm
Pharmakon Pharmaceuticals
Quantity
80 syringes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: Product contains twice the stated amount of midazolam.

Code information

Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014

Distribution pattern

IN