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.

FDA recall notice · announced May 16, 2018 · Auromedics Pharma

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: AS0317041-A, AS0317035-A; Exp August 2019
Quantity: 54,720 vials
Status: Terminated
Products in this recall event:
- 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. (D-0866-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.