Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
4 way Saline Moisturizing Mist with Eucalyptol & Menthol
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Drug: Menthol
- Recalling firm
- Novartis Consumer Health
- Origin
- NE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-211-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Menthol recalls
See all
Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
Other recalls by Novartis Consumer Health
All 2013 recalls
Class III · Low risk
Loratadine
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Class III · Low risk
Maalox Nighttime Antacid with Acid Reflux Barrier
Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Class III · Low risk
Maalox Nighttime Antacid with Acid Reflux Barrier
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Class III · Low risk
Maalox Extra Strength Antacid with Anti-Gas
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
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