The Recall Desk
SevereFDA (Drugs)·D-1355-2015·Announced 2015-09-02

PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter

PharMEDium Services is recalling 480 bags of Heparin Sodium Injection USP due to the presence of particulate matter. The product was distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

PharMEDium Services, LLC is recalling 480 bags of Heparin Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP. The recall is due to the presence of particulate matter in the product. The affected lots are 15041123S and 15041003S, with an expiration date of 04/16/15.

The firm produced these 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 product is prescription-only and was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
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.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
480

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 (3)

  • Lot #: 15041123S
  • 15041003S
  • 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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