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Recall Observatory FDA recall evidence

Drug product

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

December 19, 2024

Class II

Product summary

Firm
Hikma Injectables USA Inc
Event
Event 95993
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0174-2025

Official wording

Reason: 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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility