Recall: D-0521-2016

Class III - Minor Violations

Class IIIClassification

2015-10-20Initiated

TerminatedStatus

Teva Pharmaceutical IndustriesFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.