Enoxaparin Sodium Injection recalled due to improper storage conditions
Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
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 due to CGMP deviations affecting storage conditions for an injectable anticoagulant. Although no adverse events have been reported, improper storage represents a risk-of-harm to patients through potential loss of drug efficacy, meeting the High severity threshold.
Plain-English summary
Sandoz Inc, through Cardinal Healthcare, is recalling Enoxaparin Sodium Injection, USP, 150 mg/mL Single-Dose Syringes with Automatic Safety Device (NDC 0781-3299-69, batch SAH06821A). The recall affects units distributed nationwide in the United States.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations discovered during manufacturing. Products in the affected batch were exposed to temperatures outside the labeled storage conditions. Proper temperature control is critical to maintaining the stability and efficacy of injectable medications like enoxaparin, an anticoagulant used to prevent blood clots.
This recall affects healthcare providers, hospitals, clinics, and other entities that received products from batch SAH06821A. Patients currently using enoxaparin from this batch should not discontinue treatment without consulting their healthcare provider, as stopping anticoagulation therapy could pose serious health risks.
Healthcare providers and patients should check whether they have received products from batch SAH06821A. If the recalled product is in use, the prescribing healthcare provider should be contacted immediately for guidance. Patients with questions should contact their healthcare provider or pharmacist.
The recalled product
- Product
- ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
- Brand
- ENOXAPARIN SODIUM
- Manufacturer
- CARDINAL HEALTHCARE
- Hazard
- improper-storage
- stability-concern
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 (1)
- Batch SAH06821A
Distribution
Distributed nationwide across the United States.
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