# FDA recall D-057-2013

> **Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals** · Class I · drug recall initiated 2012-09-10.

## Product

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

## Reason for recall

Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-057-2013
- **Recalling firm:** Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2012-09-10
- **Report date:** 2012-11-28

- **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-057-2013

## Citation

> AI Analytics. FDA recall D-057-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-057-2013. Source: US FDA. Licensed CC0.

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