CEFEPIME HYDROCHLORIDE Recall D-0606-2023
Description: Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
CEFEPIME HYDROCHLORIDE Recall D-0606-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0606-2023 |
| Event ID | 92341 |
| Brand | CEFEPIME |
| Generic Name | CEFEPIME HYDROCHLORIDE |
| Manufacturer | CEFEPIME HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | CEFEPIME HYDROCHLORIDE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 107,320 vials |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230524 |
| Product NDC | 71288-008 71288-009 |
| 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) | 9470e6e2-0b42-4796-a5d6-5b09cf469091 |
| Structured Product Labeling (SPL Set ID) | 28f1c403-ab91-405e-bf52-ad81b1c66220 |
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