Why it was recalled
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
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
Lot numbers, UPCs & expiration codes
Lot #: 24I030, Exp 5/2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0521-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 20, 2015
- FDA report date
- Dec 23, 2015
- Quantity
- 3536 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceutical Industries
Original FDA data
Every field from FDA enforcement report D-0521-2016, exactly as published.
Show all FDA fields
- City
- Jerusalem
- Status
- Terminated
- Country
- Israel
- Event ID
- 72607
- Address
- 20 Kiryat HaMada Street,
- Address (line 2)
- Har Hozvim
- Code information
- Lot #: 24I030, Exp 5/2017
- Report date
- Dec 23, 2015
- Product type
- Drugs
- Recall number
- D-0521-2016
- Classification
- Class III
- Recalling firm
- Teva Pharmaceutical Industries
- Product quantity
- 3536 bottles
- Termination date
- Nov 1, 2016
- Reason for recall
- Labeling: Incorrect or Missing Lot AND/OR Exp Date.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 20, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 17, 2015