Antibiotic Injection Vials Recalled for Sterility Assurance Failure
Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.
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 antibiotic without reported illnesses or hospitalizations. The hazard—lack of sterility assurance in injectable medications—presents a genuine risk of harm, but no actual injuries are documented in the source text, meeting the criterion for High severity.
Plain-English summary
Astral SteriTech Private Ltd. is recalling Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, manufactured for Piramal Critical Care. The recall affects approximately 138,610 vials that were distributed nationwide within the United States.
The product is being recalled due to lack of assurance of sterility. All affected lots are within their expiration dates.
Piperacillin and Tazobactam is an antibiotic combination used to treat bacterial infections. A lack of sterility assurance in injectable medications represents a potential contamination risk.
Patients and healthcare providers should contact their healthcare provider or pharmacy regarding this recall.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 138,610
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 →Related recalls
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