# FDA recall D-0462-2022

> **Mylan Pharmaceuticals Inc** · Class I · drug recall initiated 2022-01-05.

## Product

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.

## Reason for recall

Labeling: Missing Label: label missing from some Semglee prefilled pens.

## Distribution

Nationwide in the USA and Thailand.

## Key facts

- **Recall number:** D-0462-2022
- **Recalling firm:** Mylan Pharmaceuticals Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-05
- **Report date:** 2022-01-26
- **Termination date:** 2024-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0462-2022

## Citation

> AI Analytics. FDA recall D-0462-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0462-2022. Source: US FDA. Licensed CC0.

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