FDAHealthDecember 19, 2024
Hikma Injectables USA Inc — 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 Compo
⚠️ Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2024
Nationwide in the USA
What's affected?
- 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
- Lot code
- 242560008D
Additional details
Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,800 syringes.
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