Recalls / Class II
Class IID-0621-2023
Product
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
- Affected lot / code info
- All lots within expiry.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Astral SteriTech Private Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 911 G I D C Makarpura, N/A, Vadodara, N/A N/A, India
Distribution
- Quantity
- 1,288,510 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-05-15
- FDA classified
- 2023-05-18
- Posted by FDA
- 2023-05-24
- Terminated
- 2024-04-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0621-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.