Triamcinolone Acetonide Cream USP recalled over manufacturing violations

Recall date

March 15, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teligent Pharma, Inc. recalls Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-…

Recall number

D-0697-2022

FDA classification

Class II

Brand / firm

Teligent Pharma, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.