Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Phar...

FDA Drug Recall #D-888-2013 — Class III — July 25, 2013

Recall Summary

Recall Number D-888-2013
Classification Class III — Low risk
Date Initiated July 25, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hi-Tech Pharmacal Co., Inc.
Location Amityville, NY
Product Type Drugs
Quantity 58,812 tubes

Product Description

Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.

Reason for Recall

Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP

Distribution Pattern

Nationwide and Puerto Rico

Lot / Code Information

Batch/Lot 619442, exp. 01/2015

Other Recalls from Hi-Tech Pharmacal Co., Inc.

Recall # Classification Product Date
D-0048-2015 Class II HydrOXYzine Hydrochloride Oral Solution, USP, 1... Apr 1, 2014
D-389-2014 Class III Acyclovir Oral Suspension, USP 200 mg/5 mL, Net... Oct 28, 2013
D-66207-001 Class III GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECON... Sep 4, 2013
D-603-2013 Class III HydrOXYzine Hydrochloride Oral Solution, USP, 1... Apr 30, 2013
D-418-2013 Class III BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg... Apr 8, 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.