Kroger Specialty Pharmacy Recalls Temozolomide Due to Processing Control Issues
Kroger Specialty Pharmacy is recalling Temozolomide 250 mg capsules due to a lack of processing controls. The recall affects specific lots dispensed 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 recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is related to processing controls rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Temozolomide 250 mg capsules (NDC 43975-0257-05, 28-day supply) because of a lack of processing controls. This FDA Class II recall involves 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 recall is voluntary and initiated by the manufacturer to address the identified quality control deficiency.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on how to proceed. Do not discard the medication until instructed by a medical professional, as it may be needed for ongoing treatment.
The recalled product
- Product
- Temozolomide 250 mg NDC 43975-0257-05 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Oncology
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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