Piperacillin and Tazobactam Injection Recalled for Lack of Sterility Assurance
Astral SteriTech recalls 223,590 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assured sterility. Patients and healthcare providers should stop use and consult their provider.
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 medication with a documented sterility assurance failure. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are rated High (3).
Plain-English summary
Astral SteriTech Private Ltd. is recalling all lots of Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, manufactured for Piramal Critical Care. The recall affects 223,590 vials that were distributed nationwide within the United States. The product is a prescription antibiotic injection.
The recall was issued because the manufacturer could not assure that the product met required sterility standards. Lack of sterility assurance in an injectable medication could expose patients to microbial contamination.
Healthcare providers and patients who have this product should discontinue use immediately and contact their healthcare provider or Piramal Critical Care for guidance on replacement therapy. Patients should not use remaining product without consulting their healthcare provider.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 223,590
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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