CEFEPIME HYDROCHLORIDE Recall D-0607-2023
Description: Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
CEFEPIME HYDROCHLORIDE Recall D-0607-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0607-2023 |
| Event ID | 92341 |
| Brand | CEFEPIME |
| Generic Name | CEFEPIME |
| Manufacturer | CEFEPIME |
| Original Package? | 1 |
| Active Substance | CEFEPIME HYDROCHLORIDE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 41,320 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 66794-209 66794-210 |
| Drug UPC | 0366794209020 0366794209419 0366794210026 |
| 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 | I8X1O0607P |
| Drug Application Number | ANDA091048 |
| Structured Product Labeling (SPL ID) | f0924684-683e-3a1b-e053-2995a90ab76e |
| Structured Product Labeling (SPL Set ID) | 83d70378-012e-4ce3-e053-2991aa0a22be |
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