Recalls / Class I
Class ID-1030-2018
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, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. 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: PP0317059-A; Exp February 2019: PP0317012-A, Exp: August 2019.
Why it was recalled
Presence of Particulate Matter: identified as glass and silicone material
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
- 73620 single-dose vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-07-02
- FDA classified
- 2018-08-02
- Posted by FDA
- 2018-07-18
- Terminated
- 2024-10-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1030-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.