FDA recall D-0119-2021

Teligent Pharma, Inc. · Class III · drug

Product

Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60

Reason for recall

Superpotent and Subpotent; low and high assay results

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2020-11-05
Report date
2020-12-09
Termination date
2024-08-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0119-2021