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
Product summary
- 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
Lack of Assurance of Sterility