Injectable Antibiotic Recalled Due to Sterility Assurance Defect
Astral SteriTech is recalling approximately 110,660 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The product was 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 a Class II recall for an injectable antibiotic with lack of sterility assurance. Because no illnesses or injuries have been reported and the hazard is theoretical, this is classified as High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Astral SteriTech Private Ltd. is recalling approximately 110,660 vials of Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial (NDC 71288-002-31) due to lack of assurance of sterility. The product was distributed nationwide within the United States.
The recall affects all lots of the recalled product within their expiration dates. For injectable medications, lack of sterility assurance means the manufacturing process did not provide adequate validation that the product met the sterility standards required for safe use. Lack of sterility creates a potential for patient harm through contamination and infection.
Patients and healthcare providers who have received or possess this medication should contact the manufacturer or the FDA for guidance. This is a Class II recall issued by the FDA.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 110,660
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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