Recall Enforment Report D-0597-2025

Drug Recall Enforcement Report Class II voluntary initiated by Cardinal Health Inc., originally initiated on 08-05-2025 for the 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 The product was recalled due to correct labeled product mispack: bags labeled for enoxaparin sodium injection, 80 mg/0.8 ml, contained enoxaparin sodium injection, 30 mg/0.3 ml. The product was distributed in Ks and the recall is currently ongoing.

Field Name	Field Value
Event ID	97380 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0597-2025 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	KS What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
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 What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	10 bags Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	09-03-2025
Recall Initiation Date	08-05-2025 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Cardinal Health Inc.
Code Info	Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	55154-3540-5; 55154-3541-5; 55154-3542-5; 55154-3543-5; 55154-3544-5; 0781-3238-01; 0781-3238-63; 0781-3246-02; 0781-3246-64; 0781-3256-03; 0781-3256-66; 0781-3262-04; 0781-3262-68; 0781-3268-05; 0781-3268-69; 0781-3298-04; 0781-3298-68; 0781-3299-05; 0781-3299-69
Status	Ongoing

Recalled Products