FDA-Drug2022-03-30Class II
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
Teligent Pharma, Inc.
Hazard
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
51,748 tubes
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0684-2022Don't want to check this manually?
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