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Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufa...

FDA Recall #D-0521-2016 — Class III — October 20, 2015

Recall #D-0521-2016 Date: October 20, 2015 Classification: Class III Status: Terminated

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.

Recalling Firm

Teva Pharmaceutical Industries — Jerusalem, N/A

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3536 bottles

Distribution

Nationwide

Code Information

Lot #: 24I030, Exp 5/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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