FDA Recall D-0866-2018
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 2381 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Reason for recall
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.
Recall record
- Recall number
D-0866-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall initiated
- 2018-05-01
- Classified by FDA Center
- 2018-06-14
- FDA published
- 2018-05-16
- Terminated
- 2024-11-06
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- AMPICILLIN AND SULBACTAM
- Generic name(s)
- AMPICILLIN SODIUM AND SULBACTAM SODIUM
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-116, 55150-117, 55150-178, 55150-179- Route(s)
- INTRAMUSCULAR, INTRAVENOUS