Kroger Specialty Pharmacy Recalls Temozolomide 20 mg Due to Processing Controls
Kroger Specialty Pharmacy is recalling Temozolomide 20 mg capsules because of a lack of processing controls. The affected products were dispensed in five states.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly when specific processing control failures are cited for a pharmaceutical product.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Temozolomide 20 mg capsules (NDC 43975-0253-05, 28-day supply) due to 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, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have this medication should contact their healthcare provider or pharmacist for instructions on how to dispose of the product or obtain a replacement. Do not take the recalled medication until you have spoken with a medical professional.
The recalled product
- Product
- Temozolomide 20 mg NDC 43975-0253-05 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Oncology / Antineoplastic
- 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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