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CriticalClass ITerminated

FDA Drug recall · Reported September 2, 2015

HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02.

Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufact…

Recall #
D-1355-2015
Affected scope
480 bags
Initiated
April 13, 2015
Verify with FDA Drug →
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Pharmedium Services, LLC recalled HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP … - a critical-severity action.

HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP … was recalled by Pharmedium Services, LLC in September 2, 2015. Reason: Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% De…. Check the official notice for the remedy. Verify recall #D-1355-2015 with the FDA Drug before acting.

The recall

Pharmedium Services, LLC issued this critical-severity FDA Drug recall-Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% De….

Critical
severity level
Class I
classification
September 2, 2015
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1355-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02.

Reason for recall

Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number D-1355-2015
Date reported September 2, 2015
Date initiated April 13, 2015
Recalling firm Pharmedium Services, LLC
Firm location Lake Forest, IL
Affected scope 480 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.

  • Check the recall number (D-1355-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

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.

Frequently Asked Questions

What product was recalled?
HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02.. Recalled by Pharmedium Services, LLC. Units affected: 480 bags.
Why was this product recalled?
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2015. Severity: Critical. Recall number: D-1355-2015.
Where was the recalled product distributed?
Distribution: Nationwide.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

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This recall: FDA Drug, reported September 2, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026