FDA recall D-0631-2018

Product

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.

Reason for recall

Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-04-06

Report date

2018-04-25

Termination date

2019-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2018