Exact FDA event identifier

Event 94522

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

Event summary

Timeline bucket: April 29, 2024
Product types: Drug
Classifications: Class I
Statuses: Completed
Recalling firm wording: Hikma Injectables USA 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

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

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

D-0508-2024

Recall number: D-0508-2024
Initiated: April 29, 2024
Classification: Class I
Status: Completed
Recalling firm: Hikma Injectables USA Inc
Quantity: Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Code information

Lot #: 240310003D, Exp 6/4/2024

Distribution pattern

CO, GA, PA, SD, WA