BLEOMYCIN SULFATE Recall D-0261-2024
Description: Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
BLEOMYCIN SULFATE Recall D-0261-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0261-2024 |
| Event ID | 93693 |
| Brand | BLEOMYCIN |
| Generic Name | BLEOMYCIN |
| Manufacturer | BLEOMYCIN |
| Original Package? | 1 |
| Active Substance | BLEOMYCIN SULFATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the USA, Netherlands and Libya |
| Quantity | 3,546 vials |
| Recall Reason | Presence of particulate matter: glass |
| Drug Classification | Class I |
| Drug Code Info | 20240131 |
| Product NDC | 61703-323 61703-332 |
| Recall Initiation Date | 20231221 |
| Report Date | 20240131 |
| Classification Date | 20240125 |
| Address | 66 Hudson St New York, NY 10013 United States |
| Recalling Firm | PFIZER |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 7DP3NTV15T |
| Drug Application Number | ANDA065031 |
| Structured Product Labeling (SPL ID) | 6615dbd2-3bb4-40b5-8599-aa46bc0bc488 |
| Structured Product Labeling (SPL Set ID) | 905e0984-2ce3-481c-b1a0-0ef0a616479a |
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