FDA recall D-0356-2021

Teligent Pharma, Inc. · Class II · drug

Product

Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60

Reason for recall

Failed Impurities/Degradation Specifications:

Distribution

Distributed Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2021-04-09
Report date: 2021-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0356-2021