Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Ampicillin and Sulbactam for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
What was recalled
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55150-117-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0866-2018
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 Ampicillin recalls
See all
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
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