Piperacillin and Tazobactam for Injection Recalled Due to Sterility Assurance Failure
Astral SteriTech recalls approximately 893,950 vials of piperacillin and tazobactam injection nationwide because the manufacturer cannot assure the product was properly sterilized.
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 of an injectable antibiotic product due to lack of sterility assurance. While no illnesses or injuries have been reported, non-sterile injectable products present a significant risk of contamination and serious infection. The severity is High because it represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd. is recalling approximately 893,950 vials of Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial (NDC 71288-003-31) manufactured for Meitheal Pharmaceuticals in Chicago, Illinois. All lots within expiry are being recalled due to lack of assurance of sterility. The product has been distributed nationwide throughout the United States.
The recall is due to the manufacturer's inability to provide assurance that the product meets sterility requirements. Piperacillin and tazobactam is an injectable antibiotic combination, and sterility is a critical requirement for all injectable drugs. Without assurance of sterility, the product may be contaminated.
No illnesses or adverse effects have been reported to date. Patients who have received this medication should contact their healthcare provider or pharmacy if they have concerns. Healthcare facilities and pharmacies should immediately quarantine remaining inventory and contact their suppliers for return instructions.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 893,950
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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