Why it was recalled
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Product description
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
Lot numbers, UPCs & expiration codes
a) 15 gram lot numbers: 549N, 550N,551N Exp. 1/2015, EB1961, Exp. 2/2017; b) 60 gram lot numbers: 546N, 547N, 548N, Exp. 1/2015, EB0144, Exp. 2/2017
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0245-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2014
- FDA report date
- Nov 19, 2014
- Quantity
- a) 59,622 Tubes; b) 43,178 Tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fougera Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0245-2015, exactly as published.
Show all FDA fields
- City
- Melville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68839
- Address
- 60 Baylis Rd
- Code information
- a) 15 gram lot numbers: 549N, 550N,551N Exp. 1/2015, EB1961, Exp. 2/2017; b) 60 gram lot numbers: 546N, 547N, 548N, Exp. 1/2015, EB0144, Exp. 2/2017
- Postal code
- 11747-3838
- Report date
- Nov 19, 2014
- Product type
- Drugs
- Recall number
- D-0245-2015
- Classification
- Class II
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Product quantity
- a) 59,622 Tubes; b) 43,178 Tubes
- Termination date
- Jun 21, 2016
- Reason for recall
- Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 28, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 12, 2014