FDA-Drug2021-09-22Class II
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
Akorn, Inc.
Hazard
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Sold states
USA Nationwide
Affected count
264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0802-2021Don't want to check this manually?
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