AuroMedics Pharma LLC recalls Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured
Recalled May 16, 2018 · FDA recall D-0866-2018 · AuroMedics Pharma
Hazard
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. · FDA Class I
Units
54,720 vials
Sold at
Nationwide in the USA and Puerto Rico
Description
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.
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.
Manufacturer(s)
AuroMedics Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →