Severity
Moderate
FDA Drug recall · Reported July 16, 2014
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Hospira Inc. recalled Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 US… - a moderate-severity action.
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 US… was recalled by Hospira Inc. in July 16, 2014. Reason: Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.. Check the official notice for the remedy. Verify recall #D-1425-2014 with the FDA Drug before acting.
The recall
Hospira Inc. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag..
Sourced from official FDA Drug enforcement records. Verify recall #D-1425-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1425-2014) was formally reported on July 16, 2014, with the manufacturer initiating the action on June 6, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Hospira Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 142,152 bags.
The documented reason for this recall is: Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
142,152 bags
Related Recalls
6
5 from same agency
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
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1425-2014 |
| Date reported | July 16, 2014 |
| Date initiated | June 6, 2014 |
| Recalling firm | Hospira Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 142,152 bags |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 16, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.