# FDA recall D-503-2013

> **TG United, Inc.** · Class II · drug recall initiated 2013-01-30.

## Product

AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant,  Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04

## Reason for recall

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

## Distribution

FL, MS, SC, LA  and TX

## Key facts

- **Recall number:** D-503-2013
- **Recalling firm:** TG United, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-01-30
- **Report date:** 2013-06-12
- **Termination date:** 2016-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooksville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-503-2013

## Citation

> AI Analytics. FDA recall D-503-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-503-2013. Source: US FDA. Licensed CC0.

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