Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure
Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection due to lack of sterility assurance. The recalled product may pose an infection risk to patients if used.
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 a risk-of-harm injectable product with a critical sterility defect, but no illnesses or injuries have been reported. The lack of sterility assurance in an injectable antibiotic presents a potential risk of serious infection, meeting the criteria for High severity.
Plain-English summary
Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial (NDC 71288-004-51), manufactured by Astral SteriTech Private Ltd. The recall affects 249,080 vials distributed nationwide within the United States.
The recall was initiated due to lack of assurance of sterility. Piperacillin and Tazobactam is an injectable antibiotic, and sterility is a critical requirement for injectable medications to ensure patient safety.
Healthcare facilities should discontinue use of the recalled product. Patients or healthcare providers with concerns about the affected product should contact the recalling firm or their healthcare provider.
The recalled product
- Product
- Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 249,080
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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