Kroger Specialty Pharmacy Recalls Kalydeco Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Kalydeco 150 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, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Kalydeco 150 mg tablet blisters (28-day supply, NDC 51167-0200-01) 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 pharmacist or healthcare provider for instructions on how to proceed.
The recalled product
- Product
- Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
- 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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