AMPICILLIN SODIUM Recall D-0598-2023
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
AMPICILLIN SODIUM Recall D-0598-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0598-2023 |
Event ID | 92341 |
Brand | AMPICILLIN AND SULBACTAM |
Generic Name | AMPICILLIN AND SULBACTAM |
Manufacturer | AMPICILLIN AND SULBACTAM |
Original Package? | 1 |
Active Substance | AMPICILLIN SODIUM SULBACTAM SODIUM |
Drug Route | INTRAVENOUS |
Distribution | Nationwide within the United States |
Quantity | 11,555 bottles |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20230524 |
Product NDC | 66794-208 |
Recall Initiation Date | 20230515 |
Report Date | 20230524 |
Classification Date | 20230518 |
Address | 911 G I D C Makarpura Vadodara, India |
Recalling Firm | Astral SteriTech Private Ltd. |
Initial Notification | Letter |
Unique Ingredient Identifier | JFN36L5S8K DKQ4T82YE6 |
Drug Application Number | ANDA090578 |
Structured Product Labeling (SPL ID) | f11ed299-663f-45d7-e053-2995a90a2f7f |
Structured Product Labeling (SPL Set ID) | 83ea5d44-cbcf-3120-e053-2a91aa0aac78 |
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