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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95993

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 19, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
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

Complete imported group

Every recalled product in this event

2 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 2

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25

D-0173-2025
Recall number
D-0173-2025
Initiated
December 19, 2024
Classification
Class II
Status
Terminated
Recalling firm
Hikma Injectables USA Inc
Quantity
1,800 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Code information

Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

D-0174-2025
Recall number
D-0174-2025
Initiated
December 19, 2024
Classification
Class II
Status
Terminated
Recalling firm
Hikma Injectables USA Inc
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Code information

Lot number: 243120003D, Use by Date: 03/11/2025

Distribution pattern

Nationwide in the USA