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
Reported: January 8, 2025 Initiated: December 19, 2024 #D-0173-2025
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.
Details
- Recalling Firm
- Hikma Injectables USA Inc
- Units Affected
- 1,800 syringes
- Distribution
- Nationwide in the USA
- Location
- Dayton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hikma Injectables USA Inc. Units affected: 1,800 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2025. Severity: Moderate. Recall number: D-0173-2025.
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