Kroger Specialty Pharmacy Recalls Gleevec Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Gleevec 100 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 severe injuries are reported in the source text.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Gleevec 100 mg tablets (NDC 00078-0401-34, 30-day supply) due to a lack of processing controls. The recall covers 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 a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have these specific tablets should stop using them and contact their pharmacist or Kroger Specialty Pharmacy for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- Gleevec 100 mg tablet NDC 00078-0401-34 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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