Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency
B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.
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 3/5 (High).
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: FDA Class II recall of a risk-of-harm product (anticoagulant with insufficient potency to prevent thrombosis). No illnesses or injuries are reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection. The affected lot is J2C017 (expiration 9/30/2023), containing 25,000 USP units of heparin sodium per 250 mL in 5% Dextrose, supplied in 250 mL Excel Containers. Approximately 30,672 units were distributed nationwide.
The recall is due to the drug being subpotent, with low anti-Factor IIa potency. This means the heparin component does not possess the expected level of activity for proper anticoagulation.
Healthcare facilities and providers who received this product should take note of the recall. Patients who received heparin from this lot should consult their healthcare provider for guidance.
The recalled product
- Product
- HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
- Brand
- HEPARIN SODIUM IN DEXTROSE
- Manufacturer
- B. Braun Medical Inc
- Hazard
- Affected units
- 30,672
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 J2C017
- Expiration: 9/30/2023.
Distribution
Distributed nationwide across the United States.
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