DEXTROSE MONOHYDRATE Recall D-0265-2022
Description: 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
DEXTROSE MONOHYDRATE Recall D-0265-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0265-2022 |
| Event ID | 89100 |
| Brand | DEXTROSE |
| Generic Name | DEXTROSE MONOHYDRATE |
| Manufacturer | DEXTROSE MONOHYDRATE |
| Original Package? | 1 |
| Active Substance | DEXTROSE MONOHYDRATE |
| Drug Route | INTRAVENOUS |
| Distribution | USA Nationwide |
| Quantity | 765 bags |
| Recall Reason | Lack of sterility assurance: bag has the potential to leak. |
| Drug Classification | Class II |
| Drug Code Info | 20211208 |
| Product NDC | 0409-7100 |
| Recall Initiation Date | 20211130 |
| Report Date | 20211208 |
| Classification Date | 20211202 |
| Address | 235 East 42nd Street New York, NY 10017-5703 United States |
| Recalling Firm | Pfizer Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | LX22YL083G |
| Drug Application Number | NDA019466 |
| Structured Product Labeling (SPL ID) | 4fb2acb9-ec11-4cfd-b820-0e68dc8df673 |
| Structured Product Labeling (SPL Set ID) | 10e98cb0-31a5-4ad1-3eaa-aa4af387a42d |
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