Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera...

FDA Drug Recall #D-0612-2017 — Class II — March 2, 2017

Recall Summary

Recall Number D-0612-2017
Classification Class II — Moderate risk
Date Initiated March 2, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fougera Pharmaceuticals Inc.
Location Melville, NY
Product Type Drugs
Quantity 14,665 tubes

Product Description

Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60

Reason for Recall

Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream

Distribution Pattern

Nationwide

Lot / Code Information

Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)

Other Recalls from Fougera Pharmaceuticals Inc.

Recall # Classification Product Date
D-0245-2015 Class II FLUOCINONIDE GEL USP, 0.05%, Rx only, For Exter... Aug 28, 2014
D-1441-2014 Class III Triamcinolone Acetonide Lotion USP, 0.025%, 60 ... Jul 3, 2014
D-1440-2014 Class III Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL... Jul 3, 2014
D-1152-2014 Class III Triamcinolone Acetonide Cream USP, 0.1%, Net Wt... Jan 29, 2014
D-1044-2014 Class III KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, ... Nov 18, 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.