FDA recall D-393-2014

Product

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

Reason for recall

Subpotent; Hydrochlorothiazide at the 9 month time point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-10-11

Report date

2014-01-08

Termination date

2015-03-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilson, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-393-2014