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
Reason for recall: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Recall initiated: 20210813
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated