FDA recall D-0877-2018

Product

Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01

Reason for recall

Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.

Distribution

Product was distributed throughout the United States

Key facts

Status

Terminated

Initiation date

2018-06-07

Report date

2018-06-20

Termination date

2019-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0877-2018