HEPARIN SODIUM Recall D-0097-2023
Description: Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
HEPARIN SODIUM Recall D-0097-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0097-2023 |
| Event ID | 91379 |
| Brand | HEPARIN SODIUM |
| Generic Name | HEPARIN SODIUM |
| Manufacturer | HEPARIN SODIUM |
| Original Package? | 1 |
| Active Substance | HEPARIN SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA. |
| Quantity | 62,088 bags |
| Recall Reason | Lack of assurance of sterility: Bags have the potential to leak. |
| Drug Classification | Class II |
| Drug Code Info | 20230111 |
| Product NDC | 0409-7620 |
| Recall Initiation Date | 20221229 |
| Report Date | 20230111 |
| Classification Date | 20230105 |
| Address | 235 East 42nd Street New York, NY 10017-5703 United States |
| Recalling Firm | Pfizer Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | ZZ45AB24CA |
| Drug Application Number | NDA018916 |
| Structured Product Labeling (SPL ID) | 9efb32ae-3ffe-4a82-8719-43762f675d8d |
| Structured Product Labeling (SPL Set ID) | 32e34077-aff1-4ec7-f9b0-b8e240768fb8 |
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