The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0741-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Taltz 80 mg/mL Pens Due to Processing Controls

Kroger Specialty Pharmacy is recalling Taltz 80 mg/mL pens distributed in five states due to a lack of processing controls.

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, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary or precautionary recall.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Taltz 80 mg/mL Pen 1-pk (NDC 00002-1445-11) 28-day supply units. 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 includes all lots remaining within their expiration date. These products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.

Consumers who have this product should contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 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

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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