Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Product description
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Lot numbers, UPCs & expiration codes
NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007
Where it was sold
USA Nationwide including Puerto Rico.
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-0309-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 27, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 37,957 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0309-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 81646
- Address
- 1090 Horsham Rd
- Code information
- NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007
- Postal code
- 19454-1505
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0309-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 37,957 bottles
- Reason for recall
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
- Distribution pattern
- USA Nationwide including Puerto Rico.
- Recall initiation date
- Nov 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2018