Kroger Specialty Pharmacy Recalls Tecfidera Capsules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Tecfidera 240 mg capsules due to a lack of processing controls. The affected units were dispensed in five states.
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 severe injuries are reported in the source text.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Tecfidera 240 mg capsules (NDC 64406-0006-02, 30-day supply) because of a lack of processing controls. The recall covers all lots remaining within their expiration 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions on how to return the medication.
The recalled product
- Product
- Tecfidera 240 mg capsule NDC 64406-0006-02 30 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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