Baxter Recalls Heparin Sodium Injection Due to Low Potency
Baxter Healthcare is recalling Heparin Sodium in Sodium Chloride Injection because the raw material was found to have low potency.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury or property damage reports, or in the absence of explicit 'no injury' statements for a subpotent drug.
Plain-English summary
Baxter Healthcare Corporation is recalling Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container. The recall was initiated because the heparin raw material used in the product was found to have low potency.
The affected product is a prescription-only intravenous medication. The recall covers 127,746 Viaflex Plus Containers distributed nationwide. The specific lots affected are N003061, N003079, and N003087, all with an expiration date of 2/29/2016.
Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM IN SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 127,746
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 (4)
- Lot #: N003061
- N003079
- and N003087
- Exp 2/29/2016
Distribution
Distributed nationwide across the United States.
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