Why it was recalled
Failed dissolution specifications
Product description
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
Lot numbers, UPCs & expiration codes
Lot #: a) 49O005, 49O006, 49O007, 49O010, Exp 02/2019; b) 49O005, 49O009, 49O010, Exp 02/2019
Where it was sold
U.S.A. 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-0381-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 19, 2018
- FDA report date
- Jan 23, 2019
- Quantity
- 181,456 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0381-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81840
- Address
- 1090 Horsham Rd
- Code information
- Lot #: a) 49O005, 49O006, 49O007, 49O010, Exp 02/2019; b) 49O005, 49O009, 49O010, Exp 02/2019
- Postal code
- 19454-1505
- Report date
- Jan 23, 2019
- Product type
- Drugs
- Recall number
- D-0381-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 181,456 bottles
- Termination date
- Aug 31, 2020
- Reason for recall
- Failed dissolution specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
- Distribution pattern
- U.S.A. nationwide
- Recall initiation date
- Dec 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2019