Recalls / Class III

Class IIID-908-2013

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 02243496, UPC 0 58478 44840 4.

Affected lot / code info

Lot #: 10093133, Exp 06/13; 10099452, Exp 09/13; 10104667, Exp 12/13; 10110926, Exp 02/14; 10114316, Exp 04/14; 10120623, Exp 07/14; 10123098, 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

129,048 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-908-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.