Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
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