Heparin Sodium Injection Recalled Due to Labeling Issue
Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II labeling issue with no reported illnesses, injuries, or deaths. The hazard is a labeling error without documented harm. Per rubric, labeling errors without reported adverse events typically score as Moderate (2).
Plain-English summary
Sagent Pharmaceuticals Inc is recalling one lot of Heparin Sodium Injection, USP (20,000 USP units per mL) supplied in 25 x 1 mL multi-dose vials. The recall involves lot WP201, which expires in February 2024, and affects 28,875 vials distributed nationwide in the United States.
The product is being recalled due to a labeling issue. The FDA has classified this as a Class II recall, meaning that use of this product may result in serious adverse health consequences or death.
Healthcare facilities and patients should not use this product. Healthcare providers should verify that any doses administered were appropriate and monitor patients as clinically indicated. Patients or providers who have concerns about medications they have received should contact their healthcare provider.
The recalled product
- Product
- HEPARIN SODIUM (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM
- Manufacturer
- Sagent Pharmaceuticals Inc
- Hazard
- mis-labeling
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#: WP201
- Exp 2/2024
Distribution
Distributed nationwide across the United States.
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