Drug 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 0067-0376-65 9.
D-904-2013
Product summary
- Event
- Event 65840
- Status
- Terminated
- Classification
- Class III
- Quantity
- 410,220 bottles
- Official record key
drug-enforcement:D-904-2013
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 #: 10093113, Exp 06/13; 10097332, Exp 08/13; 10101258, Exp 10/13; 10104632, Exp 12/13; 10108852, Exp 01/14; 10104633, 10110688, Exp 02/14; 10111944, Exp 03/14; 10114325, Exp 05/14; 10120609, 10120610, Exp 07/14; 10123084, Exp 09/14
Distribution pattern: Nationwide, Canada, and Panama.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect Or Missing