Drug 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
D-0521-2016
Product summary
- Event
- Event 72607
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3536 bottles
- Official record key
drug-enforcement:D-0521-2016
Official wording
Reason: Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Code information: Lot #: 24I030, Exp 5/2017
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing