Drug 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 02243496, UPC 0 58478 44872 5.
D-902-2013
Product summary
- Event
- Event 65840
- Status
- Terminated
- Classification
- Class III
- Quantity
- 117,816 bottles
- Official record key
drug-enforcement:D-902-2013
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 #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14
Distribution pattern: Nationwide, Canada, and Panama.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect Or Missing