Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product description
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
Lot numbers, UPCs & expiration codes
Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
Where it was sold
Product was distributed throughout the United States.
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-0317-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 20, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 5,660 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0317-2019, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Ongoing
- Country
- United States
- Event ID
- 81613
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
- Postal code
- 26505-2730
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0317-2019
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 5,660 bottles
- Reason for recall
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Nov 20, 2018
- Initial firm notification
- Press Release
- Center classification date
- Dec 14, 2018