FDA recall D-0689-2021

Teligent Pharma, Inc. · Class III · drug

Product

Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59

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-0689-2021