FDA recall D-0597-2025

Cardinal Health Inc. · Class II · drug

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

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

Key facts

Status
Ongoing
Initiation date
2025-08-05
Report date
2025-09-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2025