Kroger Specialty Pharmacy Recalls Sutent 37.5 mg Capsules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Sutent 37.5 mg capsules due to a lack of processing controls. The affected products were dispensed in five states 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, but the source text explicitly states no illnesses or injuries are reported and the hazard is a lack of processing controls, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Sutent 37.5 mg capsules (NDC 00069-0830-38) in 28-day supply packages. The recall is being conducted due to a lack of processing controls.
The affected products were dispensed between December 1, 2017, and February 12, 2018. The recall covers all lots remaining within their expiration date that were dispensed during this period. Distribution was limited to Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have this medication should contact their healthcare provider or pharmacist for instructions on how to proceed. The source text does not specify reported illnesses or injuries associated with this recall.
The recalled product
- Product
- Sutent 37.5 mg capsules x28 NDC 00069-0830-38 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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