Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 2111 and 2114, Exp 04/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-161-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 21, 2012
- FDA report date
- Feb 20, 2013
- Quantity
- 32,460 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lee Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-161-2013, exactly as published.
Show all FDA fields
- City
- South El Monte
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64180
- Address
- 1434 Santa Anita Ave
- Code information
- Lot #: 2111 and 2114, Exp 04/14
- Postal code
- 91733-3312
- Report date
- Feb 20, 2013
- Product type
- Drugs
- Recall number
- D-161-2013
- Classification
- Class II
- Recalling firm
- Lee Pharmaceuticals, Inc
- Product quantity
- 32,460 bottles
- Termination date
- Aug 22, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2013