# FDA recall D-1602-2015

> **The Compounding Pharmacy of America** · Class II · drug recall initiated 2015-06-02.

## Product

Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

## Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1602-2015
- **Recalling firm:** The Compounding Pharmacy of America
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-06-02
- **Report date:** 2015-09-23
- **Termination date:** 2016-02-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Knoxville, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1602-2015

## Citation

> AI Analytics. FDA recall D-1602-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1602-2015. Source: US FDA. Licensed CC0.

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