The Recall Desk
ModerateFDA (Drugs)·D-0763-2018·Announced 2018-05-16

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.

What this means for you

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.

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

Distributed in 5 states:

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.

See all 67 products in this recall →