Kroger Specialty Pharmacy Recalls Orkambi Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Orkambi 200 mg/125 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, which typically corresponds to a moderate severity score when no specific hospitalizations or serious injuries are reported in the source text.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Orkambi 200 mg/125 mg Tablets (NDC 51167-0809-01, 28-day supply) due to a lack of processing controls. The recall includes all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018.
The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have these tablets should stop using them and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 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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