# FDA recall D-438-2014

> **Specialty Medicine Compounding Pharmacy** · Class II · drug recall initiated 2013-10-19.

## Product

Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

## Reason for recall

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

## Distribution

Hospitals, clinics, physicians, and patients in the Michigan area only.

## Key facts

- **Recall number:** D-438-2014
- **Recalling firm:** Specialty Medicine Compounding Pharmacy
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-19
- **Report date:** 2014-01-22
- **Termination date:** 2014-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Lyon, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-438-2014

## Citation

> AI Analytics. FDA recall D-438-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-438-2014. Source: US FDA. Licensed CC0.

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