The Recall Desk
ModerateFDA (Drugs)·D-0925-2018·Announced 2018-07-18

Sanofi Recalls Admelog Insulin Pens Due to Temperature Abuse

Sanofi-Aventis is recalling 3,214 Admelog insulin pens because they may not have been shipped at the proper temperature.

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 hazard involves potential temperature abuse which may affect product stability, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Sanofi-Aventis U.S. LLC is recalling 3,214 prefilled pens of Admelog (insulin lispro injection), 100 units/mL (U-100). The product is identified by Lot # 7F021B and an expiration date of 6/30/20. The recall is being conducted because product samples may not have been shipped at the proper temperature.

The recalled product is a prescription-only physician sample that is not for sale. It is distributed nationwide. The specific NDC for the recalled packaging is 0024-5925-00.

Consumers and healthcare providers should stop using the affected pens and contact Sanofi-Aventis or their healthcare provider for further instructions. Do not use the product if it has been exposed to improper temperatures.

The recalled product

Product
ADMELOG (INSULIN LISPRO)
Brand
ADMELOG
Affected units
3,214

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 (2)

  • Lot #: 7F021B
  • Exp 6/30/20

Distribution

Distributed nationwide across the United States.

Same brand · ADMELOG

Same manufacturer · Sanofi-Aventis U.S. LLC

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