Class II · Moderate risk Terminated
Ceftriaxone for Injection
Reason Lack of Assurance of Sterility
Ceftriaxone for Injection USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
What was recalled
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-644-01
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0358-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ceftriaxone recalls
See all
Class II · Moderate risk Terminated
Ceftriaxone for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ceftriaxone for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ceftriaxone for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ceftriaxone for Injection
Reason Lack of Assurance of Sterility
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