The Recall Desk

FDA (Drugs) recall action 92341

Astral SteriTech Private Ltd. recalled 52 products on 2023-05-24

The FDA (Drugs) publishes a recall like this one as 52 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 52 pages.

Products
52
Announced
2023-05-24
Critical
0
Units
12,934,605

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–52 of 52

  • HighFDA (Drugs)··2023-05-24

    Piperacillin and Tazobactam for Injection Recalled Due to Sterility Assurance Failure

    Astral SteriTech recalls approximately 893,950 vials of piperacillin and tazobactam injection nationwide because the manufacturer cannot assure the product was properly sterilized.

    Product
    Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-05-24

    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.

    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
    Category
    Distribution
    0 states