Piperacillin and Tazobactam Injection Recalled Due to Sterility Assurance Issue
Approximately 936,680 vials of Piperacillin and Tazobactam for Injection are being recalled nationwide due to lack of assurance of sterility. All affected lots remain within their expiration dates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile injectable pharmaceutical with lack of assurance of sterility. Per the severity rubric, Class II recalls without reported hospitalizations are scored at 3 (High), representing risk-of-harm products where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd. is recalling approximately 936,680 vials of Piperacillin and Tazobactam for Injection, 3.375 grams per vial (NDC 70594-079-02), manufactured for Xellia Pharmaceuticals USA, LLC. The product is distributed nationwide.
The recall was initiated due to lack of assurance of sterility. Piperacillin and Tazobactam is a sterile injectable antibiotic that must meet strict sterility requirements. All affected lots remain within their expiration dates.
Healthcare providers and pharmacies who have received this product should immediately stop distribution and quarantine remaining inventory. Patients who have received injections from affected vials should contact their healthcare provider. Healthcare professionals should contact their supplier or Xellia Pharmaceuticals USA, LLC for instructions on returning the product.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 936,680
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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