The Recall Desk
ModerateFDA (Drugs)·D-0426-2021·Announced 2021-06-02

Cardinal Health Recalls Enoxaparin Syringes Due to Temperature Excursions

Cardinal Health is recalling 64 boxes of Enoxaparin Dofium Injection 150mg/1ml syringes due to intermittent temperature excursions during storage.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 64 boxes of Enoxaparin Dofium Injection, 150mg/1ml, 10x1ml single-dose syringes (NDC/UPC 60505-0798-4). The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled product is CV006.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES
Affected units
64

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • CV006

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →