Recalls / Class II

Class IID-0697-2022

Product

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.

Affected lot / code info

Batch: a) 15123, Exp. 2/28/2022; 15875, Exp. 8/31/2022; 16115, Exp. 10/31/2022; b) 15123, 15201, Exp. 2/28/2022; 15477, Exp. 4/30/2022; 15897, Exp. 8/31/2022; 16090, Exp. 10/31/2022; 16374, Exp. 1/31/2023; 16676, Exp. 3/31/2023; 17109, Exp. 7/31/2023; c) 15241, Exp. 2/28/2022; 16610, Exp. 3/31/2023; d) 15121, 15127, 15191, 15201, 15278, Exp. 2/28/2022;15386, 15567, Exp. 4/30/2022; 15875, Exp. 8/31/2022; 16050, 16051, 16115, Exp. 10/31/2022; 16165, 16201, Exp. 11/30/2022; 16609, 16610, 16624, Exp. 3/31/2023; 16700, Exp. 4/30/2023; 16732, Exp. 5/31/2023; 17081, 17108, Exp. 7/31/2023

Why it was recalled

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

Recalling firm

Firm

Teligent Pharma, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

105 Lincoln Avenue, N/A, Buena, New Jersey 08310

Distribution

Quantity

721,225 tubes; 90,893 jars

Distribution pattern

Nationwide in the USA and Puerto Rico

Timeline

Recall initiated

2022-03-15

FDA classified

2022-03-21

Posted by FDA

2022-03-30

Terminated

2024-06-17

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0697-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.