Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box...

FDA Recall #D-0882-2022 — Class I — April 5, 2022

Recall #D-0882-2022 Date: April 5, 2022 Classification: Class I Status: Completed

Product Description

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59

Reason for Recall

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Recalling Firm

Cardinal Health Inc. — Dublin, OH

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

1 box

Distribution

NM only

Code Information

Unknown

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated