FDA Recall Ampicillin And Sulbactam

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Ampicillin And Sulbactam with NDC 55150-116 was initiated on 05-01-2018 as a Class I recall due to 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. The latest recall number for this product is D-0866-2018 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0866-201805-01-201805-16-2018Class I54,720 vialsAmpicillin 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.Ongoing
D-0339-201801-02-201802-14-2018Class I53,040 vialsAmpicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.