FDA recall D-905-2013

Novartis Consumer Health · Class III · drug

Product

Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count (NDC 0067-6279-90) (UPC 3 0067-0343-90 3) tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

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-905-2013