FDA recall D-0690-2021

Teligent Pharma, Inc. · Class III · drug

Product

Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2021-06-22
Report date
2021-07-28
Termination date
2024-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0690-2021