# FDA recall D-1410-2019

> **Preferred Pharmaceuticals, Inc** · Class II · drug recall initiated 2019-06-10.

## Product

Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01

## Reason for recall

CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

## Distribution

Distribution was made to CA and FL.

## Key facts

- **Recall number:** D-1410-2019
- **Recalling firm:** Preferred Pharmaceuticals, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-10
- **Report date:** 2019-06-26
- **Termination date:** 2023-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Anaheim, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1410-2019

## Citation

> AI Analytics. FDA recall D-1410-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1410-2019. Source: US FDA. Licensed CC0.

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