Drug Enforcement D-0597-2025

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

Status

Ongoing

Classification

Class II

Report Date

September 3, 2025

Termination Date

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Product Information

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
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
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
KS

Location & Firm

Recalling firm
Cardinal Health Inc.
Address
7000 Cardinal Pl

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0597-2025
Event ID
97380
Recall initiation date
August 5, 2025
Center classification date
August 22, 2025
Code info
Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
More code info
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