Drug 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.
D-0866-2018
Product summary
- Event
- Event 79996
- Status
- Terminated
- Classification
- Class I
- Quantity
- 54,720 vials
- Official record key
drug-enforcement:D-0866-2018
Official wording
Reason: 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.
Code information: Lot #: AS0317041-A, AS0317035-A; Exp August 2019
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter