Exact FDA event identifier

Event 78503

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

Event summary

Timeline bucket: October 13, 2017
Product types: Drug
Classifications: Class II
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40

D-0080-2018

Recall number: D-0080-2018
Initiated: October 13, 2017
Classification: Class II
Status: Terminated
Recalling firm: PharMEDium Services, LLC.
Quantity: 499 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: out of specification result for potency

Code information

Lot#: 172820134M, Exp 01/18

Distribution pattern

CA, IL