Drug recall D-0866-2018
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.
Lots and codes
Lot #: AS0317041-A, AS0317035-A; Exp August 2019
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 54,720 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 1, 2018
- Terminated
- November 6, 2024
Related products
- Ampicillin and Sulbactam – drug information
- NDC 55150-179 Ampicillin and Sulbactam · Ampicillin Sodium 2 g/1; Sulbactam Sodium 1 g/1 · Eugia US LLC
- NDC 55150-117 Ampicillin and Sulbactam · Ampicillin Sodium 2 g/1; Sulbactam Sodium 1 g/1 · Eugia US LLC
- NDC 55150-178 Ampicillin and Sulbactam · Ampicillin Sodium 1 g/1; Sulbactam Sodium .5 g/1 · Eugia US LLC
- NDC 55150-116 Ampicillin and Sulbactam · Ampicillin Sodium 1 g/1; Sulbactam Sodium .5 g/1 · Eugia US LLC