Recalls / Class III

Class IIID-903-2013

Product

Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290.

Affected lot / code info

Lot #: a) 10095538, Exp 07/13; 10099449, Exp 09/13; 10104663, Exp 01/14; 10111110, Exp 02/14; 10114312, Exp 04/14; 10120619, Exp 07/14; b) 10095537, Exp 07/13; 10099451, Exp 09/13; 10104664, Exp 01/14; 10111112, Exp 02/14; 10114313, Exp 04/14; 10120620, Exp 07/14; c) 10095528, Exp 07/13; 10106998, Exp 01/14; 10120618, Exp 07/14

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

112,728 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-903-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.