Fondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation
AuroMedics Pharma LLC is recalling 11,520 units of Fondaparinux Sodium Injection nationwide due to out-of-specification potency. Patients should contact their healthcare provider immediately.
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: FDA Class II designation indicates a serious quality defect. The product is an anticoagulant that failed potency specifications, creating a risk that patients may not receive adequate blood clot prevention. This qualifies as a risk-of-harm product where no reported illnesses or injuries have yet occurred.
Plain-English summary
AuroMedics Pharma LLC is recalling approximately 11,520 units of Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL in single-dose prefilled syringes nationwide. The product failed to meet specifications for assay potency, meaning the medication contains less active ingredient than labeled. Lot CFN200020, with an expiration date of November 2022, is affected.
Fondaparinux is an anticoagulant used to prevent and treat blood clots. Patients who received this medication may not have received the intended therapeutic dose, potentially placing them at risk for clotting complications. The FDA classified this as a Class II recall.
Patients who received injections from this lot should contact their healthcare provider immediately to discuss whether additional monitoring or alternative anticoagulation therapy is needed. Healthcare providers and patients should not use any units from Lot CFN200020. Unused product should be returned to the pharmacy or dispensing facility.
The recalled product
- Product
- FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
- Brand
- FONDAPARINUX SODIUM
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 11,520
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 # CFN200020
- EXP Nov. 2022
Distribution
Distributed nationwide across the United States.
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