D-0613-2023 Class II Terminated
FDA drug recall D-0613-2023 was initiated by Astral SteriTech Private Ltd. on May 15, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated April 5, 2024). Affected quantity: 73,475 vials.
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
- 73,475 vials
Product Description
Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
All lots within expiry.