Why it was recalled
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Product description
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
Lot numbers, UPCs & expiration codes
Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
Where it was sold
KS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0597-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 5, 2025
- FDA report date
- Sep 3, 2025
- Quantity
- 10 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health Inc.
Original FDA data
Every field from FDA enforcement report D-0597-2025, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 97380
- Address
- 7000 Cardinal Pl
- Code information
- Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
- Postal code
- 43017-1091
- Report date
- Sep 3, 2025
- Product type
- Drugs
- Recall number
- D-0597-2025
- Classification
- Class II
- Recalling firm
- Cardinal Health Inc.
- Product quantity
- 10 bags
- Reason for recall
- Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- KS
- Recall initiation date
- Aug 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2025