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Class II Recall
Teligent Pharma, Inc.
Product
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Classification
Class II
Status
Terminated
Lot
Batch: a) 15125, Exp. 2/28/2022; 15385, Exp. 3/31/2022; 15613, Exp. 5/31/2022; 16027, Exp. 9/30/2022; 16204, Exp. 11/30/2022; 16376, Exp. 1/31/2023; 16707, Exp. 3/31/2023; b) 15385, Exp. 3/31/2022; 15752, Exp. 6/30/2022; 15346, Exp. 9/30/2022; 16188, Exp. 11/30/2022; 16567, Exp. 2/28/2023; 16730, Exp. 4/30/2023; c)15752, Exp. 6/30/2022; 16188, Exp. 11/30/2022
Date
2022-03-30
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.