The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0625-2023·Announced 2023-05-24

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.

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 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
Hazard
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 →

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