Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Recall Number: D-0692-2022

Firm: Teligent Pharma, Inc.

Classification: Class II

Status: Terminated

Report Date: 20220330

Initiation Date: 20220315

Termination Date: 20240617

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

Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.