B. Braun Recalls Heparin Sodium Bags Due to Low Potency
B. Braun Medical Inc. is recalling 40,176 bags of Heparin Sodium in Dextrose because testing showed the drug had lower potency than required by USP specifications.
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: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is a subpotent drug issue rather than a high-risk pathogen or structural defect.
Plain-English summary
B. Braun Medical Inc. is recalling 40,176 bags of Heparin Sodium in Dextrose (NDC 0264-9587-20). The affected product is Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag. The specific lot number is J7B259, with an expiration date of August 31, 2019.
The recall was initiated because out-of-specification results were identified for the drug's anti-factor IIa potency. This test is intended to ensure that the potency of heparin is within the United States Pharmacopeia (USP) specifications. The product was distributed nationwide in the USA.
This is a prescription-only medication. Healthcare providers and pharmacies should stop using the affected lot and contact B. Braun Medical Inc. for further instructions. Patients who have received this medication should contact their healthcare provider if they have questions or concerns.
The recalled product
- Product
- HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
- Brand
- HEPARIN SODIUM IN DEXTROSE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 40,176
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 #: J7B259
- Exp 31 Aug 2019
Distribution
Distributed nationwide across the United States.
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