Class II Recall

Teligent Pharma, Inc.

Product
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
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: 15435, Exp. 3/31/2022; 16960, Exp. 5/31/2023
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