Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 ...

FDA Drug Recall #D-575-2013 — Class III — February 19, 2013

Recall Summary

Recall Number D-575-2013
Classification Class III — Low risk
Date Initiated February 19, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Novartis Consumer Health
Location Lincoln, NE
Product Type Drugs
Quantity 219,600 tubes

Product Description

Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

Distribution Pattern

Nationwide and Puerto Rico, and Panama. Military distribution made.

Lot / Code Information

Lot number and exp date: 10104145 30-Apr-2013. (Vertical package) and Lot number and exp date: 10109587 30-Apr-2013, 10111508 31-May-2013; 10119095 31-Jul-2013 and 10119096 30-Sep-2013 (Horizontal package).

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-910-2013 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-902-2013 Class III Maalox Extra Strength Antacid with Anti-Gas (ca... 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.