FDA recall D-0893-2018

Qualgen, LLC · Class III · drug

Product

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-06-08
Report date: 2018-07-11
Termination date: 2020-11-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Edmond, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0893-2018