Home / Recalls / Astral SteriTech Private Ltd. / D-0594-2023

D-0594-2023 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
35,087 bottles

Product Description

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75

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-0589-2023 Class II — Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manuf (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-0590-2023 Class II — Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufact (May 15, 2023)
  • D-0599-2023 Class II — Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, (May 15, 2023)
  • D-0598-2023 Class II — Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, (May 15, 2023)
  • D-0597-2023 Class II — Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: (May 15, 2023)
  • D-0580-2023 Class II — Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critic (May 15, 2023)
  • D-0616-2023 Class II — Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xelli (May 15, 2023)
  • D-0626-2023 Class II — Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mf (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)