The Recall Desk
CriticalFDA (Drugs)·D-1357-2015·Announced 2015-09-02

PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter

PharMEDium Services, LLC is recalling 240 bags of Heparin Sodium Injection USP 25,000 Units in 250 mL bags due to the presence of particulate matter.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

PharMEDium Services, LLC is recalling 240 bags of Heparin Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP. The product is packaged in 250 mL bags and is prescription-only. The specific lot number is 15041038S, with an expiration date of 04/16/15. The National Drug Code (NDC) is 61553-419-02.

The recall was initiated because 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. The distribution of the affected product was nationwide.

Healthcare providers and patients should stop using the affected product and contact PharMEDium Services, LLC for further instructions or replacement. The FDA has classified this recall as Class I, indicating a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.

The recalled product

Product
HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
240

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 15041038S
  • Exp 04/16/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Pharmedium Services, LLC

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Same hazard · particulate matter

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