Akorn, Inc. recalls Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottl
Recalled September 22, 2021 · FDA recall D-0802-2021 · Akorn
Hazard
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. · FDA Class II
Units
264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
Sold at
USA Nationwide
Description
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
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
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →