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Recall Observatory FDA recall evidence

Drug product

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

December 19, 2024

Class II

Product summary

Firm
Hikma Injectables USA Inc
Event
Event 95993
Status
Terminated
Classification
Class II
Quantity
1,800 syringes
Official record key
drug-enforcement:D-0173-2025

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility