# FDA recall D-0661-2016

> **Safecor Health, LLC** · Class II · drug recall initiated 2015-03-02.

## Product

Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL  amber bottle, Rx Only,  Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.

## Reason for recall

Defective Container: Confirmed customer complaints of leaking bottles.

## Distribution

NJ

## Key facts

- **Recall number:** D-0661-2016
- **Recalling firm:** Safecor Health, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-02
- **Report date:** 2016-02-17
- **Termination date:** 2016-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woburn, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2016

## Citation

> AI Analytics. FDA recall D-0661-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0661-2016. Source: US FDA. Licensed CC0.

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