# FDA recall D-1051-2013

> **Medaus, Inc.** · Class II · drug recall initiated 2013-08-23.

## Product

L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183

## Reason for recall

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1051-2013
- **Recalling firm:** Medaus, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-23
- **Report date:** 2013-09-25
- **Termination date:** 2014-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Birmingham, AL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1051-2013

## Citation

> AI Analytics. FDA recall D-1051-2013. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1051-2013. Source: US FDA. Licensed CC0.

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