CEFTRIAXONE SODIUM Recall D-0612-2023
Description: Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
CEFTRIAXONE SODIUM Recall D-0612-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0612-2023 |
| Event ID | 92341 |
| Brand | CEFTRIAXONE |
| Generic Name | CEFTRIAXONE |
| Manufacturer | CEFTRIAXONE |
| Original Package? | 1 |
| Active Substance | CEFTRIAXONE SODIUM |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 65,950 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 66794-211 66794-213 66794-214 |
| Drug UPC | 0366794213027 0366794211023 0366794212020 |
| 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 | 023Z5BR09K |
| Drug Application Number | ANDA091049 |
| Structured Product Labeling (SPL ID) | f092a251-81a4-ed5c-e053-2a95a90af949 |
| Structured Product Labeling (SPL Set ID) | 88312fc0-35d5-2945-e053-2a95a90a34bd |
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