FDA recall D-0521-2016

Product

Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98

Reason for recall

Labeling: Incorrect or Missing Lot AND/OR Exp Date.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-10-20

Report date

2015-12-23

Termination date

2016-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jerusalem, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0521-2016