The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0762-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Stelara Due to Processing Control Issues

Kroger Specialty Pharmacy is recalling Stelara 90 mg/MI PFS due to lack of processing controls. The recall affects units 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Stelara 90 mg/MI PFS (NDC 57894-0061-03, 84 days supply) 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 number of units recalled or report any illnesses or injuries associated with the product.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance on what to do next. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply
Manufacturer
Kroger Specialty Pharmacy, Inc.
Category
Drug — Biologic
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

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 →

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