Drug product
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
D-1030-2018
Product summary
- Event
- Event 80390
- Status
- Terminated
- Classification
- Class I
- Quantity
- 73620 single-dose vials
- Official record key
drug-enforcement:D-1030-2018
Official wording
Reason: Presence of Particulate Matter: identified as glass and silicone material
Code information: Lot: PP0317059-A; Exp February 2019: PP0317012-A, Exp: August 2019.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter