FDA recall D-0802-2021

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.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2021-08-13

Report date

2021-09-22

Termination date

2022-08-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0802-2021