Baxter Recalls Subpotent Heparin Sodium Injection Due to Raw Material Issues
Baxter Healthcare is recalling specific lots of Heparin Sodium in Sodium Chloride Injection because the raw material was found to be subpotent and out of specification.
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 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 quality deviations like subpotency in a critical medication.
Plain-English summary
Baxter Healthcare Corporation is recalling 145,350 containers of Heparin Sodium in Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container. The affected product is identified by NDC 0338-0431-03 and includes lots N002998 and N003004 (expiring 12/31/15) and lot N003038 (expiring 01/31/2016). The recall is being conducted because the heparin raw material used in these lots produced out-of-specification results, indicating the drug was subpotent.
The affected product was distributed nationwide. This is a prescription-only medication intended for intravenous use. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected lots of Heparin Sodium in Sodium Chloride Injection. Baxter Healthcare is responsible for notifying customers and ensuring the product is removed from the market. Consumers with questions regarding this recall should contact Baxter Healthcare directly.
The recalled product
- Product
- HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM IN SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp
- Category
- Drug — Anticoagulant
- Affected units
- 145,350
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)
- Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15
- and lot N003038 exp. 01/31/2016
Distribution
Distributed nationwide across the United States.
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