FDA recall D-0338-2021

Teligent Pharma, Inc. · Class III · drug

Product

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

Reason for recall

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Distribution

USA Nationwide

Key facts

Status: Terminated
Initiation date: 2021-02-02
Report date: 2021-05-05
Termination date: 2024-08-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0338-2021