# FDA recall D-1506-2019

> **Pharma-Natural Inc.** · Class II · drug recall initiated 2019-06-21.

## Product

NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR  00917, NDC 52083-699-16.

## Reason for recall

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

## Distribution

Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-1506-2019
- **Recalling firm:** Pharma-Natural Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-21
- **Report date:** 2019-07-31
- **Termination date:** 2021-10-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1506-2019

## Citation

> AI Analytics. FDA recall D-1506-2019. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-1506-2019. Source: US FDA. Licensed CC0.

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