# FDA recall D-0575-2023

> **Sanofi-Aventis U.S. LLC** · Class II · drug recall initiated 2023-04-11.

## Product

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05

## Reason for recall

Lack of Assurance of Sterility: Malformed crimped collar seal

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0575-2023
- **Recalling firm:** Sanofi-Aventis U.S. LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-04-11
- **Report date:** 2023-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0575-2023

## Citation

> AI Analytics. FDA recall D-0575-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0575-2023. Source: US FDA. Licensed CC0.

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