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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94208

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

Open FDA event record

Event summary

Timeline bucket
March 12, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Hikma Pharmaceuticals 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

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

Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01

D-0392-2024
Recall number
D-0392-2024
Initiated
March 12, 2024
Classification
Class II
Status
Ongoing
Quantity
22,644 ampuls

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Code information

Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024

Distribution pattern

Nationwide within the United States