Recalls / Class III
Class IIID-0521-2016
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
- Brand name
- Irbesartan And Hydrochlorothiazide
- Generic name
- Irbesartan And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Irbesartan
- Route
- Oral
- NDCs
- 0093-8232, 0093-8238
- FDA application
- ANDA077369
- Affected lot / code info
- Lot #: 24I030, Exp 5/2017
Why it was recalled
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Recalling firm
- Firm
- Teva Pharmaceutical Industries
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Kiryat HaMada Street,, Har Hozvim, Jerusalem, N/A N/A, Israel
Distribution
- Quantity
- 3536 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-10-20
- FDA classified
- 2015-12-17
- Posted by FDA
- 2015-12-23
- Terminated
- 2016-11-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0521-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.