D-0598-2023 Class II Terminated
FDA drug recall D-0598-2023 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: 11,555 bottles.
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
- 11,555 bottles
Product Description
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
All lots within expiry.