FDA (Drugs) recall action 65840

Novartis Consumer Health recalled 9 products on 2013-08-28

The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2013-08-28
Critical: 0
Units: 4,452,948

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels
Novartis Consumer Health is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
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 80
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling c
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling
Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number and expiration date may be illegible on the packaging.
Product
Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels
Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Miss
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Extra Strength Antacid Due to Illegible Labeling
Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the packaging.
Product
Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets because the lot number and expiration date may be illegible on the packaging.
Product
Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Nighttime Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 8
Category
Distribution
0 states
LowFDA (Drugs)··2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels
Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle.
Product
Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-6
Category
Distribution
0 states