FDA recall D-1500-2014

Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90

Reason for recall

Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-07-11

Report date

2014-08-06

Termination date

2016-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1500-2014