Drug product
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
D-0926-2018
Product summary
- Event
- Event 79995
- Status
- Terminated
- Classification
- Class I
- Quantity
- 77,400 vials
- Official record key
drug-enforcement:D-0926-2018
Official wording
Reason: Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Code information: Lot #s: PP0317061-A, PP0317049-A; EXP August 2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter