Unlikely to cause harm — often a labeling or packaging issue.
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
| Brand name | IRBESARTAN AND HYDROCHLOROTHIAZIDE |
| Generic name | IRBESARTAN AND HYDROCHLOROTHIAZIDE |
| Active ingredient(s) | HYDROCHLOROTHIAZIDE, IRBESARTAN |
| Distributed by / for | TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960 |
| NDC | 0093-8238-98 |
| Full product label | 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 |
| Recalling firm | Teva Pharmaceutical Industries |
| Distribution | Nationwide |
| Quantity | 3536 bottles |
| Recall initiated | 2015-10-20 |
| Report date | 2015-12-23 |
| Recall completed | 2016-11-01 |
| Recall number | D-0521-2016 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Jerusalem N/A Israel |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗