Recall
FDAHealthAugust 5, 2025

Cardinal Health Inc. — 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

⚠️ Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Is this relevant to me?

Geography
KS
Source agency
FDA
Category
Health
Published
August 5, 2025

KS

What's affected?

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
UPC
0055154354059
Lot code
AD08033AA

Additional details

Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 10 bags.

View original FDA notice →

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