D-0583-2023 Class II Terminated
FDA drug recall D-0583-2023 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 Apr 5, 2024). Affected quantity: 45,160 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2023
- Initiation Date
- May 15, 2023
- Termination Date
- Apr 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,160 vials
Product Description
Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
All lots within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0583-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026