# FDA recall D-0422-2015

> **Mylan Institutional LLC** · Class II · drug recall initiated 2015-02-18.

## Product

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

## Reason for recall

Lack of Assurance of Sterility; due to leaking vials

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0422-2015
- **Recalling firm:** Mylan Institutional LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-18
- **Report date:** 2015-04-01
- **Termination date:** 2017-02-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0422-2015

## Citation

> AI Analytics. FDA recall D-0422-2015. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0422-2015. Source: US FDA. Licensed CC0.

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