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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
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