CEFEPIME HYDROCHLORIDE Recall D-0610-2023
Description: Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02
CEFEPIME HYDROCHLORIDE Recall D-0610-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0610-2023 |
| Event ID | 92341 |
| Brand | CEFEPIME HYDROCHLORIDE |
| Generic Name | CEFEPIME HYDROCHLORIDE |
| Manufacturer | CEFEPIME HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | CEFEPIME HYDROCHLORIDE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 964,420 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 70594-089 70594-090 |
| 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 | ANDA212721 |
| Structured Product Labeling (SPL ID) | 5ceacb56-4bff-4036-aadd-2843c6fe45cc |
| Structured Product Labeling (SPL Set ID) | 91f72dcf-eb1f-4fc6-b9a2-042424012e3e |
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