FDA Recalls Heparin Sodium Injection for Endotoxin Contamination
Baxter Healthcare Corporation is recalling 44,208 containers of Heparin Sodium in Sodium Chloride Injection nationwide after endotoxin testing revealed out-of-limit results. The contamination poses a risk of serious adverse reactions in patients receiving the intravenous medication.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which requires a minimum severity score of 4. Although no illnesses or injuries are reported in the source text, microbial contamination with endotoxin in a sterile intravenous product poses a significant risk of serious harm.
Plain-English summary
Baxter Healthcare Corporation is recalling Heparin Sodium in Sodium Chloride Injection, a sterile intravenous anticoagulant medication. The affected product is supplied in 1,000 mL single-dose containers with a concentration of 2 units/mL. The recall involves lot number N008235 with an expiration date of August 31, 2024, and affects 44,208 containers distributed nationwide in the United States.
The recall was initiated after endotoxin testing revealed out-of-limit results, indicating potential microbial contamination of the sterile product. Endotoxins are pyrogens released from gram-negative bacteria that can cause serious systemic reactions, including fever and septic shock, when injected. The contamination means the product does not meet the sterility standards required for safe intravenous administration.
Affected inventory should be immediately removed from use. Patients who received injections from this recalled lot should contact their healthcare provider. Healthcare providers with inventory from lot number N008235 should stop distribution and follow recall procedures.
The recalled product
- Product
- HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM IN SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Injectable Anticoagulant
- Affected units
- 44,208
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 # N008235
- Exp 8/31/2024
Distribution
Distributed nationwide across the United States.
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Similar recalls
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