Triamcinolone Acetonide Ointment USP recall: CGMP Deviations
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.
Why was Triamcinolone Acetonide Ointment USP recalled?
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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.
- Recalling firm
- Teligent Pharma, Inc.
- Quantity
- 482,003 tubes; 45,583 jars
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- March 30, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)