Kroger Specialty Pharmacy Recalls Cimzia 200 mg/mL PFS Kits
Kroger Specialty Pharmacy is recalling Cimzia 200 mg/mL PFS Kits due to a lack of processing controls. The affected lots 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 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 explicitly states no illnesses or injuries have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Cimzia 200 mg/mL PFS Kit #2 (NDC 50474-0710-79), a 28-day supply. The recall is being conducted due to a lack of processing controls.
The affected product consists of all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018. The product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have this product should contact their healthcare provider or pharmacist for instructions on how to proceed. No specific adverse health consequences or injuries have been reported in the source text.
The recalled product
- Product
- Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Biologic / Injectable
- 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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