Recalls / Class II
Class IID-0245-2015
Product
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)
- Affected lot / code info
- 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
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>.
Recalling firm
- Firm
- Fougera Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 60 Baylis Rd, Melville, New York 11747-3838
Distribution
- Quantity
- a) 59,622 Tubes; b) 43,178 Tubes
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-08-28
- FDA classified
- 2014-11-12
- Posted by FDA
- 2014-11-19
- Terminated
- 2016-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0245-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.