FDA Drugs recall ·
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled… recall
- Recall number
- D-0173-2025
- Date
- (initiated December 19, 2024)
- Company / brand
- Hikma Injectables USA Inc
36 Stults Rd, Dayton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 1,800 syringes
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0173-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.