Recalls / Class III

Class IIID-904-2013

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.

Affected lot / code info

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

Why it was 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.

Recalling firm

Firm

Novartis Consumer Health

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

10401 Hwy 6, N/A, Lincoln, Nebraska 68517-9626

Distribution

Quantity

410,220 bottles

Distribution pattern

Nationwide, Canada, and Panama.

Timeline

Recall initiated

2013-08-06

FDA classified

2013-08-20

Posted by FDA

2013-08-28

Terminated

2014-11-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-904-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.