PlainRecalls
FDA Drug Moderate Class II Terminated

Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.

Reported: March 30, 2022 Initiated: March 15, 2022 #D-0696-2022

Product Description

Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.

Reason for Recall

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

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
159,994 tubes
Distribution
Nationwide in the USA and Puerto Rico
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.. Recalled by Teligent Pharma, Inc.. Units affected: 159,994 tubes.
Why was this product recalled?
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 30, 2022. Severity: Moderate. Recall number: D-0696-2022.