The Recall Desk
ModerateFDA (Drugs)·D-0788-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Sutent 50 mg Capsules Due to Processing Controls

Kroger Specialty Pharmacy is recalling Sutent 50 mg capsules due to a lack of processing controls. The affected products 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 does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Sutent 50 mg capsules (NDC 00069-0550-38) in 42-day supplies. The recall is being conducted due to a lack of processing controls.

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

Consumers who have these products should contact their healthcare provider or pharmacist for guidance on what to do next.

The recalled product

Product
Sutent 50 mg capsules x28 NDC 00069-0550-38 42 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 →