Status
Terminated
Drug Enforcement D-909-2013
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.
Classification
Class III
Report Date
August 28, 2013
Termination Date
November 4, 2014
Product Information
- Product description
- Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3.
- Product quantity
- 23,856 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Canada, and Panama.
Location & Firm
- Recalling firm
- Novartis Consumer Health
- Address
-
10401 Hwy 6, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-909-2013
- Event ID
- 65840
- Recall initiation date
- August 6, 2013
- Center classification date
- August 20, 2013
- Code info
- Lot #: 10107000, Exp 07/13; 10114319, Exp 01/14
- More code info
- —