PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 23, 2015 Initiated: October 20, 2015 #D-0521-2016

Product Description

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.

Details

Units Affected
3536 bottles
Distribution
Nationwide
Location
Jerusalem, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceutical Industries. Units affected: 3536 bottles.
Why was this product recalled?
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 23, 2015. Severity: Low. Recall number: D-0521-2016.