Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure
Astral SteriTech recalls approximately 393,930 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility, per FDA Class II classification.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall for lack of sterility assurance with no reported illnesses or hospitalizations. Per the rubric, theoretical hazards without reported injury qualify as High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd. is recalling Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial (NDC 70594-080-02), manufactured for Xellia Pharmaceuticals USA, LLC. Approximately 393,930 vials have been distributed nationwide within the United States. The recall affects all lots currently within their expiration dates.
The recall was initiated due to lack of assurance of sterility. Piperacillin and Tazobactam is an intravenous antibiotic combination used to treat bacterial infections. Injectable medications must meet strict sterility standards to ensure patient safety.
This is an FDA Class II recall. The affected product has been distributed to healthcare facilities nationwide.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 393,930
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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