The Recall Desk
ModerateFDA (Drugs)·D-0764-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Praluent 75 mg Pens for Processing Control Issues

Kroger Specialty Pharmacy is recalling Praluent 75 mg pens due to a lack of processing controls. The affected units were 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 explicitly states no illnesses or injuries were reported, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply. The recall was initiated because of a lack of processing controls.

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

Consumers who have this product should contact their healthcare provider or pharmacist for instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply

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 →