FDA recall D-907-2013

Novartis Consumer Health · Class III · drug

Product

Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.

Reason for recall

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.

Distribution

Nationwide, Canada, and Panama.

Key facts

Status
Terminated
Initiation date
2013-08-06
Report date
2013-08-28
Termination date
2014-11-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-907-2013