FDA recall D-0436-2017

Town and Country Compounding and Consultation Services, LLC · Class III · drug

Product

HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459

Reason for recall

Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-10-18
Report date
2017-01-25
Termination date
2021-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ridgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2017