The Recall Desk
ModerateFDA (Drugs)·D-0760-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Dupixent Due to Processing Control Issues

Kroger Specialty Pharmacy is recalling Dupixent 300 mg/2 mL prefilled syringes due to a lack of processing controls. The recall affects units dispensed in five states between December 2017 and February 2018.

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 the source text does not report any illnesses, injuries, or hospitalizations. The hazard is described as a lack of processing controls without specific reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Dupixent 300 mg/2 mL prefilled syringes (PFS) with NDC 00024-5914-01. The recall is being conducted due to a lack of processing controls. The affected product is a 28-day supply.

The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018. The product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply
Manufacturer
Kroger Specialty Pharmacy, Inc.
Category
Drug — Biologic / Injectable
Hazard

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)

  • All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 67 recalled by Kroger Specialty Pharmacy, 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 67 products in this recall →

Related recalls

Same manufacturer · Kroger Specialty Pharmacy, Inc.

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Same hazard · processing control deficiency

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