Recalls / Class II

Class IID-0699-2022

Product

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.

Affected lot / code info

Batch: a) 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15946, Exp. 9/30/2023; b) 14674, Exp. 11/30/2022; 14760, 14798, Exp. 12/31/2022; 14896, Exp. 1/31/2023; 15000, Exp. 1/31/2023; 15591, Exp. 4/30/2023; 15802, 15833, Exp. 7/31/2023; 15872, Exp. 8/31/2023; 15946, Exp. 9/30/2023; 16069, Exp. 10/31/2023; 16199, Exp. 11/30/2023; 16429, Exp. 2/29/2024; 16608, 16712, Exp. 3/31/2024; 17080, Exp. 7/31/2024; c)15065, Exp. 2/28/2023; 15072, Exp. 2/28/2023; 15436, Exp. 3/31/2023; 15810, Exp. 7/31/2023; 15877, Exp. 8/31/2023; 15974, Exp. 9/30/2023; 16045, Exp. 10/31/2023; 16269, Exp. 12/31/2023; 16270, Exp. 12/31/2023; 16566, Exp. 3/31/2024; 16713, Exp. 3/31/2024; 17042, Exp. 6/30/2024; 17068, Exp. 7/31/2024

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

482,003 tubes; 45,583 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-0699-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.