FDA Drug recall D-161-2013
12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Prou…
- FDA Drug
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Prou… by Lee Pharmaceuticals, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-161-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-21 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lee Pharmaceuticals |
| Distribution | US |
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) Sinus Nasal Spray, Distributed by: Select Brand Distributors, Pine Bluff, AR 71603, UPC 015127 02305 4, NDC 15127-889-30.
Reason
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.
Identifiers
| upc | 070038612261 |
|---|---|
| upc | 093351126239 |
| upc | 639194045513 |
| upc | 023558692305 |
| upc | 840986015175 |
| upc | 635515990128 |
| upc | 011822145763 |
| upc | 015127023054 |
| code_info | Lot #: 2111 and 2114, Exp 04/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-161-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.