Heparin Sodium and Dextrose Injection Recalled Due to Subpotency
B. Braun Medical Inc. is recalling 1,380 units of Heparin Sodium in Dextrose injection because the product is subpotent with lower anti-factor IIa potency than specified.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving subpotent anticoagulant medication. The product is a risk-of-harm product where patients may receive inadequate blood-clotting prevention. No illnesses or injuries have been reported, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical Inc. is recalling Heparin Sodium and Dextrose injection (25,000 USP units per 250 mL) distributed nationwide in the United States. The affected lot is Lot Number J1P154N with an expiration date of May 31, 2023, and includes 1,380 units.
The recall was initiated because the product is subpotent—it contains lower anti-factor IIa potency than specified on the label. This is a Class II recall due to the potential for harm from inadequate anticoagulation.
Healthcare providers should stop using this lot immediately and contact B. Braun Medical Inc. for guidance. Patients who received this product should consult their healthcare provider about whether they require additional monitoring or follow-up.
The recalled product
- Product
- HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
- Brand
- HEPARIN SODIUM IN DEXTROSE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Intravenous Injectable
- Hazard
- subpotency
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 (3)
- Lot Number: J1P154N
- Exp: 31 May
- 2023
Distribution
Distributed nationwide across the United States.
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Same brand · HEPARIN SODIUM IN DEXTROSE
- HighHeparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency
FDA (Drugs) · 2023-03-15
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