The Recall Desk
ModerateFDA (Drugs)·D-0799-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Kisqali Tablets Due to Processing Controls

Kroger Specialty Pharmacy is recalling Kisqali 200 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 or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Kisqali 600 Dose 63 tablet 200 mg (NDC 00078-0874-63) 28-day supply. The recall is being conducted due to a lack of processing controls. The affected lots are those remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.

The recalled product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The source text does not specify the exact number of units affected or report any illnesses or injuries associated with the product.

Consumers who have this product should contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the medication.

The recalled product

Product
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 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 →