Class II
Ongoing
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
This recall is currently active, issued September 3, 2025. It was issued by Cardinal Health Inc..
- Company
- Cardinal Health Inc.
- Recall Initiated
- August 5, 2025
- Posted
- September 3, 2025
- Recall Number
- D-0597-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10 bags
- Firm Location
- Dublin, OH, United States
- Official Source
- View on FDA website ↗
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
Distribution
KS
Lot / Code Info
Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
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