FDA-Drug2018-05-16Class I
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.
AuroMedics Pharma LLC
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.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
54,720 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2018Don't want to check this manually?
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