FDA recall D-1391-2019

Teligent Pharma, Inc. · Class III · drug

Product

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2019-05-20
Report date: 2019-06-26
Termination date: 2025-01-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1391-2019