D-0173-2025 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2025
- Initiation Date
- December 19, 2024
- Termination Date
- November 12, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,800 syringes
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Distribution Pattern
Nationwide in the USA
Code Information
Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025