AMPICILLIN SODIUM Recall D-0596-2023
Description: Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
AMPICILLIN SODIUM Recall D-0596-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0596-2023 |
| 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 | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 58,770 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 66794-241 66794-242 |
| Drug UPC | 0366794242027 0366794241020 |
| 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 | ANDA090579 |
| Structured Product Labeling (SPL ID) | f48ec7a8-42a6-88be-e053-2995a90ac849 |
| Structured Product Labeling (SPL Set ID) | f48ecb78-1ca5-8c1f-e053-2a95a90a183d |
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