Recalls / Class II
Class IID-0597-2025
Product
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
- Brand name
- Enoxaparin Sodium
- Generic name
- Enoxaparin Sodium
- Active ingredient
- Enoxaparin Sodium
- Route
- Subcutaneous
- NDCs
- 55154-3540, 55154-3541, 55154-3542, 55154-3543, 55154-3544, 0781-3238, 0781-3246, 0781-3256, 0781-3262, 0781-3268 +2 more
- FDA application
- ANDA077857
- Affected lot / code info
- Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
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
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Cardinal Health 107, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 10 bags
- Distribution pattern
- KS
Timeline
- Recall initiated
- 2025-08-05
- FDA classified
- 2025-08-22
- Posted by FDA
- 2025-09-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0597-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.