# FDA recall D-0037-2015

> **Qualitest Pharmaceuticals** · Class II · drug recall initiated 2014-08-06.

## Product

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC

## Reason for recall

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0037-2015
- **Recalling firm:** Qualitest Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-08-06
- **Report date:** 2014-10-29
- **Termination date:** 2016-02-02

- **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-0037-2015

## Citation

> AI Analytics. FDA recall D-0037-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0037-2015. Source: US FDA. Licensed CC0.

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