# FDA recall D-0489-2022

> **Ultra Seal Corporation** · Class II · drug recall initiated 2022-01-24.

## Product

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00

## Reason for recall

cGMP deviations

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0489-2022
- **Recalling firm:** Ultra Seal Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-24
- **Report date:** 2022-02-09
- **Termination date:** 2023-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Paltz, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2022

## Citation

> AI Analytics. FDA recall D-0489-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0489-2022. Source: US FDA. Licensed CC0.

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