FDAFDA · Food and drugs·Recall number D-0597-2025
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01
Published September 3, 2025 · Recall initiated: August 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ENOXAPARIN SODIUM
- Manufacturer
- Cardinal Health Inc.
- Distributor
- KS
- UPC
- 0055154354059
- Lot
- Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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