# FDA recall D-0569-2016

> **Amerita Specialty Infusion Services** · Class II · drug recall initiated 2015-12-24.

## Product

Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614

## Reason for recall

Lack of Assurance of Sterility

## Distribution

AZ only.  No foreign distribution.

## Key facts

- **Recall number:** D-0569-2016
- **Recalling firm:** Amerita Specialty Infusion Services
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-24
- **Report date:** 2016-01-27
- **Termination date:** 2016-02-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Prescott, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0569-2016

## Citation

> AI Analytics. FDA recall D-0569-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0569-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*