Recalls / Class I
Class ID-0926-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Piperacillin And Tazobactam
- Generic name
- Piperacillin Sodium And Tazobactam Sodium
- Active ingredients
- Piperacillin Sodium, Tazobactam Sodium
- Route
- Intravenous
- NDCs
- 55150-119, 55150-120, 55150-121
- FDA application
- ANDA065498
- Affected lot / code info
- Lot #s: PP0317061-A, PP0317049-A; EXP August 2019
Why it was recalled
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 77,400 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-05-01
- FDA classified
- 2018-07-17
- Posted by FDA
- 2018-05-23
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0926-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.