Why it was recalled
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Product description
Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
Lot numbers, UPCs & expiration codes
Lot # 2J23, Exp 09/15
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-155-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 18, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 46,752 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Matrixx Initiatives Inc
Original FDA data
Every field from FDA enforcement report D-155-2013, exactly as published.
Show all FDA fields
- City
- Scottsdale
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 63917
- Address
- 8515 E Anderson Dr
- Code information
- Lot # 2J23, Exp 09/15
- Postal code
- 85255-5461
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-155-2013
- Classification
- Class I
- Recalling firm
- Matrixx Initiatives Inc
- Product quantity
- 46,752 bottles
- Termination date
- Nov 14, 2013
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Dec 18, 2012
- Initial firm notification
- Press Release
- Center classification date
- Feb 7, 2013