FDA-Drug2022-03-30Class II

Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 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
482,003 tubes; 45,583 jars
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0699-2022

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