Kroger Specialty Pharmacy Recalls Cyclophosphamide Capsules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Cyclophosphamide 50 mg capsules due to a lack of processing controls. The affected lots were 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential but unreported adverse health consequences.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Cyclophosphamide 50 mg capsules (NDC 00054-0383-25) due to a lack of processing controls. The recall covers all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.
The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The source text does not specify the exact number of units recalled or report any specific illnesses or injuries associated with the product.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Pharmaceutical
- 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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