FDA Recall D-1030-2018
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 2283 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, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30
Reason for recall
Presence of Particulate Matter: identified as glass and silicone material
Recall record
- Recall number
D-1030-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-07-02
- Classified by FDA Center
- 2018-08-02
- FDA published
- 2018-07-18
- Terminated
- 2024-10-01
- 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