# FDA recall D-394-2014

> **Qualitest Pharmaceuticals** · Class III · drug recall initiated 2013-12-16.

## Product

Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).

## Reason for recall

Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-394-2014
- **Recalling firm:** Qualitest Pharmaceuticals
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-12-16
- **Report date:** 2014-01-08
- **Termination date:** 2014-10-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-394-2014

## Citation

> AI Analytics. FDA recall D-394-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-394-2014. Source: US FDA. Licensed CC0.

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