Home / Recalls / Astral SteriTech Private Ltd. / D-0609-2023

D-0609-2023 Class II Terminated

Recalled by Astral SteriTech Private Ltd. — Vadodara, N/A

Recall Details

Product Type
Drugs
Report Date
May 24, 2023
Initiation Date
May 15, 2023
Termination Date
April 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
550,160 vials

Product Description

Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

All lots within expiry.

Other recalls by Astral SteriTech Private Ltd.

  • D-0611-2023 Class II — Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Criti (May 15, 2023)
  • D-0615-2023 Class II — Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Pir (May 15, 2023)
  • D-0618-2023 Class II — Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xel (May 15, 2023)
  • D-0589-2023 Class II — Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manuf (May 15, 2023)
  • D-0621-2023 Class II — Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, M (May 15, 2023)
  • D-0594-2023 Class II — Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, (May 15, 2023)
  • D-0627-2023 Class II — Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, M (May 15, 2023)
  • D-0596-2023 Class II — Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. fo (May 15, 2023)
  • D-0624-2023 Class II — Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mf (May 15, 2023)
  • D-0616-2023 Class II — Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xelli (May 15, 2023)