# FDA recall D-0604-2022

> **Perrigo Company PLC** · Class II · drug recall initiated 2021-10-26.

## Product

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10

## Reason for recall

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0604-2022
- **Recalling firm:** Perrigo Company PLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-26
- **Report date:** 2022-03-02
- **Termination date:** 2023-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allegan, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0604-2022

## Citation

> AI Analytics. FDA recall D-0604-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0604-2022. Source: US FDA. Licensed CC0.

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