Status
Terminated
Drug Enforcement D-0597-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
May 24, 2023
Termination Date
April 5, 2024
Product Information
- Product description
- Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
- Product quantity
- 1,001,110 vials
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Astral SteriTech Private Ltd.
- Address
-
911 G I D C Makarpura, N/A
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0597-2023
- Event ID
- 92341
- Recall initiation date
- May 15, 2023
- Center classification date
- May 18, 2023
- Code info
- All lots within expiry.
- More code info
- —