Class II Recall

Teligent Pharma, Inc.

Product
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, 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) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; b) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023; 17046, Exp. 6/30/2023; c) 15856, Exp. 8/31/2022; d) 15856, Exp. 8/31/2022; 17026, Exp. 6/30/2023
Date
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.
Teligent Pharma, Inc. — Class II Recall | MedicineWatch US