# FDA recall D-0331-2015

> **Qualitest Pharmaceuticals** · Class III · drug recall initiated 2014-12-22.

## Product

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL  35811

## Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0331-2015
- **Recalling firm:** Qualitest Pharmaceuticals
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-22
- **Report date:** 2015-01-14
- **Termination date:** 2016-02-01

- **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-0331-2015

## Citation

> AI Analytics. FDA recall D-0331-2015. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0331-2015. Source: US FDA. Licensed CC0.

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