Drug 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 80000899, UPC 0 58478 10091 3.
D-909-2013
Product summary
- Event
- Event 65840
- Status
- Terminated
- Classification
- Class III
- Quantity
- 23,856 bottles
- Official record key
drug-enforcement:D-909-2013
Official wording
Reason: 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.
Code information: Lot #: 10107000, Exp 07/13; 10114319, Exp 01/14
Distribution pattern: Nationwide, Canada, and Panama.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect Or Missing