The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0622-2023·Announced 2023-05-24

Piperacillin and Tazobactam Injectable Recalled for Sterility Assurance Issue

Astral SteriTech is recalling 204,860 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The FDA classified this as a Class II recall affecting nationwide distribution.

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 an injectable pharmaceutical due to lack of assurance of sterility. Although no illnesses or injuries have been reported, non-sterile injectable drugs pose a serious risk of contamination and infection. This qualifies as a risk-of-harm product without reported injury, placing it in the High severity category.

Plain-English summary

Astral SteriTech Private Ltd. is recalling all lots of Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial (NDC 72572-577-10) due to lack of assurance of sterility. The FDA classified this as a Class II recall. Non-sterile injectable medications could pose a contamination risk to patients.

The recall affects approximately 204,860 vials distributed nationwide within the United States. All lots within their expiration dates are included. The product was manufactured for Civica Inc. of Lehi, Utah.

Persons who received this product should not use it and should contact their healthcare provider. Healthcare facilities and pharmacies should verify their inventory against the NDC number and take appropriate steps to prevent distribution of affected vials.

The recalled product

Product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable
Hazard
Affected units
204,860

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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