Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not...
FDA Drug Recall #D-1441-2014 — Class III — July 3, 2014
Recall Summary
| Recall Number | D-1441-2014 |
| Classification | Class III — Low risk |
| Date Initiated | July 3, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fougera Pharmaceuticals Inc. |
| Location | Melville, NY |
| Product Type | Drugs |
| Quantity | 3,594 Bottles |
Product Description
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
Reason for Recall
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Distribution Pattern
Nationwide
Lot / Code Information
Lot: 849R, Exp 04/2015
Other Recalls from Fougera Pharmaceuticals Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0612-2017 | Class II | Desonide Ointment, 0.05%, NET WT 60 grams tubes... | Mar 2, 2017 |
| D-0245-2015 | Class II | FLUOCINONIDE GEL USP, 0.05%, Rx only, For Exter... | Aug 28, 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 taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.