# FDA recall D-1301-2019

> **Unipharma, Llc.** · Class II · drug recall initiated 2019-05-02.

## Product

DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010

## Reason for recall

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

## Distribution

Nationwide and Venezuela

## Key facts

- **Recall number:** D-1301-2019
- **Recalling firm:** Unipharma, Llc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-02
- **Report date:** 2019-05-22
- **Termination date:** 2020-11-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1301-2019

## Citation

> AI Analytics. FDA recall D-1301-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1301-2019. Source: US FDA. Licensed CC0.

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