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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73297

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

Open FDA event record

Event summary

Timeline bucket
February 11, 2016
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

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

D-0871-2016
Recall number
D-0871-2016
Initiated
February 11, 2016
Classification
Class I
Status
Terminated
Recalling firm
Pharmakon Pharmaceuticals
Quantity
75 Syringes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

Code information

Lot #: E52418EV11C, Exp 03/19/2016

Distribution pattern

IN and IL