# FDA recall D-138-2013

> **Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals** · Class I · drug recall initiated 2012-12-06.

## Product

Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.

## Reason for recall

Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-138-2013
- **Recalling firm:** Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-06
- **Report date:** 2013-02-06
- **Termination date:** 2021-07-20

- **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-138-2013

## Citation

> AI Analytics. FDA recall D-138-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-138-2013. Source: US FDA. Licensed CC0.

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