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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Prescription Medication
- Hazard
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
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.
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