The Recall Desk
ModerateFDA (Drugs)·D-0783-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Sprycel 80 mg Tablets Due to Processing Controls

Kroger Specialty Pharmacy is recalling Sprycel 80 mg tablets dispensed in five states due to a lack of processing controls.

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, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Sprycel 80 mg tablets (NDC 00003-0855-22, 30-day supply) due to a lack of processing controls. The recall affects all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.

The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall is classified as Class II by the U.S. Food and Drug Administration.

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

The recalled product

Product
Sprycel 80 mg tablet NDC 00003-0855-22 30 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 →