Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets,...

FDA Drug Recall #D-902-2013 — Class III — August 6, 2013

Recall Summary

Recall Number D-902-2013
Classification Class III — Low risk
Date Initiated August 6, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Novartis Consumer Health
Location Lincoln, NE
Product Type Drugs
Quantity 117,816 bottles

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.

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 Pattern

Nationwide, Canada, and Panama.

Lot / Code Information

Lot #: 10097345, Exp 08/13; 10104668, Exp 01/14; 10114317, Exp 03/14; 10120624, Exp 07/14

Other Recalls from Novartis Consumer Health

Recall # Classification Product Date
D-022-2014 Class III Loratadine, USP 10 mg, Antihistamine, packaged ... Sep 3, 2013
D-909-2013 Class III Maalox Nighttime Antacid with Acid Reflux Barri... Aug 6, 2013
D-907-2013 Class III Maalox, Regular Strength Antacid (calcium carbo... Aug 6, 2013
D-910-2013 Class III Maalox Nighttime Antacid with Acid Reflux Barri... Aug 6, 2013
D-906-2013 Class III Maalox Extra Strength Antacid (calcium carbonat... Aug 6, 2013

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.