Teligent Pharma, Inc. — Class II Recall

Product

Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 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) 15599, Exp. 4/30/2022; 16108, Exp. 10/31/2022; 16471, Exp. 2/28/2023; 16680, Exp. 3/31/2023; b) 15120, 15126, 15592, Exp. 2/28/2022; 15599, Exp. 4/30/2022; 16108, 16145, Exp. 10/31/2022; 16261, Exp. 12/31/2022; 16456, 16471, Exp. 2/28/2023; 16552, 16680, Exp. 3/31/2023

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.