Enoxaparin Sodium injection recalled for mislabeled dosage concentration
Bags of Enoxaparin Sodium Injection labeled as 80 mg/0.8 mL contained the 30 mg/0.3 mL concentration. This mislabeling could lead to incorrect dosing if providers or patients rely on the outer bag label.
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 recall for a medication mispack creating a dosing error risk with an anticoagulant. No reported illnesses or injuries, placing this in the High severity category per the rubric for risk-of-harm products without yet-reported injury.
Plain-English summary
Cardinal Health Inc. is recalling Enoxaparin Sodium Injection, 30 mg/0.3 mL, distributed in bags of 5 prefilled syringes. The affected bags are labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, but contain the 30 mg/0.3 mL strength instead.
This mispack creates a risk of dosing error if healthcare providers or patients rely on the outer bag label rather than the inner syringe labels. The affected product was distributed in Kansas. Affected lots include outer package Lot SAD08033AA (NDC 55154-3543-5) and inner label Lot SAF13211A (NDC 0781-3238-01).
Patients and healthcare providers should verify the strength on the individual syringe label, not the outer bag label. Return the product to the pharmacy or healthcare provider if the mislabeled bags are identified. No illnesses or injuries have been reported.
The recalled product
- Product
- ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
- Brand
- ENOXAPARIN SODIUM
- Manufacturer
- Cardinal Health Inc.
- Hazard
- mislabeling
- dosage-error
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)
- Outer package - NDC 55154-3543-5
- Lot SAD08033AA Inner label - NDC 0781-3238-01
- Lot SAF13211A
UPCs (4)
- 0055154354059
- 0055154354455
- 0055154354257
- 0055154354158
Distribution
Distributed in 1 state:
- KS
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