FDA recall D-0978-2018

Mylan Pharmaceuticals Inc. · Class III · drug

Product

Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01

Reason for recall

Subpotent Drug

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2018-07-09
Report date
2018-07-18
Termination date
2020-01-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0978-2018