# FDA recall D-1043-2013

> **JCB Labs LLC** · Class II · drug recall initiated 2013-08-23.

## Product

Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

## 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 and Guam

## Key facts

- **Recall number:** D-1043-2013
- **Recalling firm:** JCB Labs LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-23
- **Report date:** 2013-09-25
- **Termination date:** 2014-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wichita, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2013

## Citation

> AI Analytics. FDA recall D-1043-2013. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1043-2013. Source: US FDA. Licensed CC0.

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