Class III · Low risk
SinuFrin Decongestant
Sub-potent Drug
Zicam Extreme Congestion Relief
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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.
Affected NDC
62750-0005-10
Compare with the code on your package — it is the most precise check available.
Drug: Oxymetazoline
- Recalling firm
- Matrixx Initiatives Inc
- NDC code
- 62750-005-10
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-155-2013 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxymetazoline recalls
See all
Class II · Moderate risk
Quality Choice No Drip Severe Congestion Nasal Pump Mist
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration
Lack of Assurance of Sterility
Other microbial contamination recalls from 2012
All microbial contamination recalls
Class II · Moderate risk
Hillyard
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Class II · Moderate risk
12-Hour Sinus
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.
Class II · Moderate risk
NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube
Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.
Class II · Moderate risk
Limed Bone Gelatin
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
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