The Recall Desk
ModerateFDA (Drugs)·D-0734-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Humira Pen Kits Due to Processing Controls

Kroger Specialty Pharmacy is recalling Humira Pen Sub-q and Psor Kits due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.

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, which is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is described generally as a lack of processing controls without specifying a high-risk pathogen or structural defect.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Humira Pen Sub-q Kit (40 mg/0.8 mL) and Humira Pen Psor Kit (40 mg/0.8 mL) 28-day supply kits. The recall was initiated due to a lack of processing controls. The affected products are prescription-only medications.

The recall covers all lots remaining within their expiration dates that were dispensed between December 1, 2017, and February 12, 2018. These products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.

Consumers who have these specific Humira Pen kits should stop using them and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only,
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

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 →

Related recalls

Same manufacturer · Kroger Specialty Pharmacy, Inc.

See all →

Same hazard · processing controls

See all →