Kroger Specialty Pharmacy Recalls Orkambi Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Orkambi 100 mg/125 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
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 source text does not report any illnesses, injuries, or deaths, and the hazard is described as a lack of processing controls without specific contamination details, fitting the criteria for a voluntary precautionary recall or minor labeling/processing error.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Orkambi 100 mg/125 mg Tablets (NDC 51167-0700-02) in 28-day supply packages. The recall is being conducted due to a lack of processing controls.
The affected product includes all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018. The distribution pattern indicates the product was available in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on next steps. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 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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