Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701

Recall Number: D-0802-2021

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20210922

Initiation Date: 20210813

Termination Date: 20220817

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701