The Recall Desk
ModerateFDA (Drugs)·D-0745-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Repatha Due to Lack of Processing Controls

Kroger Specialty Pharmacy is recalling Repatha 140 mg/mL Sureclick AI 2-pk due to lack of processing controls. The recall affects units dispensed in MS, LA, AR, IL, and FL.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, aligning with a Moderate severity rating for a drug recall with a procedural defect.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Repatha 140 mg/mL Sureclick AI 2-pk (NDC 55513-0760-02, 28 days supply) due to a lack of processing controls. The FDA has classified this as a Class II recall.

The recall covers all lots remaining within expiry 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 recalled product

Product
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 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 →