Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling approximately 1.3 million vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility during manufacturing.
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 of an injectable medication where sterility cannot be assured. Injectable medications pose inherent risk of serious infection if contaminated, though no actual contamination has been confirmed and no illnesses reported. Classified as high-risk based on the potential for harm from sterility failure.
Plain-English summary
Astral SteriTech Private Ltd. is recalling approximately 1,288,510 vials of Piperacillin and Tazobactam for Injection, USP (3.375 grams per vial), manufactured for Civica Inc. in Lehi, Utah. The product was distributed nationwide within the United States.
The recall was initiated due to lack of assurance of sterility. This means the manufacturer cannot confirm that all units meet required sterility standards. All affected lots remain within their expiration dates and may still be in circulation.
No illnesses or injuries have been reported in connection with this recall. Patients and healthcare providers who have this medication should consult their healthcare provider for guidance on appropriate follow-up.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 1,288,510
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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