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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72478

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

Open FDA event record

Event summary

Timeline bucket
May 22, 2015
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Pharmedium Services, 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

Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.

D-0658-2016
Recall number
D-0658-2016
Initiated
May 22, 2015
Classification
Class I
Status
Terminated
Recalling firm
Pharmedium Services, LLC
Quantity
19 Syringes

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

Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

Code information

Lot #:151370066M, Exp. 08/15/2015

Distribution pattern

WI