FDAFDA · Food and drugs·Recall number D-0173-2025
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
Published January 8, 2025 · Recall initiated: December 19, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hikma Injectables USA Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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