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.
Product description
Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5.
Lot numbers, UPCs & expiration codes
Lot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14
Where it was sold
Nationwide, Canada, and Panama.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-902-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 6, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 117,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-902-2013, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 65840
- Address
- 10401 Hwy 6
- Code information
- Lot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14
- Postal code
- 68517-9626
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-902-2013
- Classification
- Class III
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 117,816 bottles
- Termination date
- Nov 4, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5.
- Distribution pattern
- Nationwide, Canada, and Panama.
- Recall initiation date
- Aug 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2013