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)
Reported: November 19, 2014 Initiated: August 28, 2014 #D-0245-2015
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)
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>.
Details
- Recalling Firm
- Fougera Pharmaceuticals Inc.
- Units Affected
- a) 59,622 Tubes; b) 43,178 Tubes
- Distribution
- Nationwide and Puerto Rico
- Location
- Melville, NY
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Fougera Pharmaceuticals Inc.. Units affected: a) 59,622 Tubes; b) 43,178 Tubes.
Why was this product 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>.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 19, 2014. Severity: Moderate. Recall number: D-0245-2015.
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