The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0629-2023·Announced 2023-05-24

Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

The FDA is recalling 169,520 vials of Piperacillin and Tazobactam injectable antibiotic due to lack of assurance of sterility. The affected vials were distributed nationwide.

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: This is an FDA Class II recall of injectable antibiotic vials due to lack of assurance of sterility, a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Astral SteriTech Private Ltd. is recalling all lots of Piperacillin and Tazobactam for Injection, USP 2.25 g per vial (NDC 70594-078-02) due to a lack of assurance of sterility. A total of 169,520 vials have been affected by this recall.

The affected vials were distributed nationwide throughout the United States. This is a prescription injectable antibiotic product.

Healthcare providers and individuals who have received or may be in possession of this product should consult with their healthcare provider regarding their treatment and use of the product. The FDA recommends that affected products not be used.

All recalled vials are within their expiration dates. Any adverse events or health concerns related to this product should be reported to the FDA.

The recalled product

Product
Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable Antibiotic
Hazard
Affected units
169,520

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.

See all 52 products in this recall →

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