# FDA recall D-161-2013

> **Lee Pharmaceuticals, Inc** · Class II · drug recall initiated 2012-12-21.

## Product

12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO  64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0 9335112623 9; c) sinus relief nasal spray, Distributed By DUANE reade, 440 Ninth Avenue, NY, NY  10001, UPC 6 39194 04551 3; d) 12 Hour Nasal Relief Sinus Nasal Spray, Distributed by: Lee Pharmaceuticals, South El Monte, CA  91733, UPC 0 23558 69230 5;  e) Sinus Nasal Spray, Premier Value, Distributed By: Chain Drug Consortium, LLC, 2300 NW Corporate Blvd., Suite 115, Boca Raton, FL  33431, UPC 8 40986 01517 5, NDC 68016-0307-03; f) Nasal Relief Sinus Squeeze Spray, Distributed By Quality Choice, Novi, Michigan 48376-0995, UPC 6 35515 99012 8, NDC 63868-0062-30; g) sinus relief nasal spray, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA  17011, UPC 0 11822 14576 3; h) Si

## Reason for recall

Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-161-2013
- **Recalling firm:** Lee Pharmaceuticals, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-21
- **Report date:** 2013-02-20
- **Termination date:** 2013-08-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South El Monte, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-161-2013

## Citation

> AI Analytics. FDA recall D-161-2013. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-161-2013. Source: US FDA. Licensed CC0.

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