Recalls / Class II
Class IID-0616-2023
Product
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
- Affected lot / code info
- All lots within expiry.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Astral SteriTech Private Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 911 G I D C Makarpura, N/A, Vadodara, N/A N/A, India
Distribution
- Quantity
- 66,125 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-05-15
- FDA classified
- 2023-05-18
- Posted by FDA
- 2023-05-24
- Terminated
- 2024-04-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0616-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.