FDA recall D-0064-2021

Product

Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310

Reason for recall

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

Distribution

United States Nationwide

Key facts

Status

Terminated

Initiation date

2020-09-28

Report date

2020-11-11

Termination date

2022-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0064-2021