FDA Recall D-0926-2018
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 1877 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Recall record
- Recall number
D-0926-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-05-01
- Classified by FDA Center
- 2018-07-17
- FDA published
- 2018-05-23
- Terminated
- 2023-06-21
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- PIPERACILLIN AND TAZOBACTAM
- Generic name(s)
- PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-119, 55150-120, 55150-121- Route(s)
- INTRAVENOUS