The last Recall Enforcement Report for Heparin Sodium And Dextrose with NDC 0409-7794 was initiated on 06-06-2014 as a Class II recall due to lack of assurance of sterility: confirmed consumer report of fluid leaking from primary container of bag. The latest recall number for this product is D-1425-2014 and the recall is currently terminated as of 04-03-2015 .
Recall Number D-1425-2014
Field Name |
Field Value |
Event ID |
68631 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number |
D-1425-2014 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification |
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern |
Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description |
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62 |
Reason For Recall |
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity |
142,152 bags Product Quantity The amount of product subject to recall. |
Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date |
07-16-2014 |
Recall Initiation Date |
06-06-2014 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date |
04-03-2015 What is the Date Terminated? The date that FDA terminated the recall. |
Initial Firm Notification |
Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type |
Drugs |
Recalling Firm |
Hospira Inc. |
Code Info |
Lot # 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages |
0409-7793-52; 0409-7793-62; 0409-7793-13; 0409-7793-23; 0409-7794-52; 0409-7794-62; 0409-4520-02; 0409-4520-30 |
Status |
Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
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View Recall Report |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
This product is EXCLUDED from the official NDC directory .