Why it was recalled
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Product description
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Lot numbers, UPCs & expiration codes
Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
Where it was sold
Product was distributed throughout the United States to several major distributors, 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-0332-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 4, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 32,284 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF)
Original FDA data
Every field from FDA enforcement report D-0332-2019, exactly as published.
Show all FDA fields
- City
- Sinnar, Nashik District
- Status
- Ongoing
- Country
- India
- Event ID
- 81707
- Address
- F-4 F-12, Malegaon M.I.D.C., Sinnar
- Code information
- Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0332-2019
- Classification
- Class II
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF)
- Product quantity
- 32,284 HDPE bottles
- Reason for recall
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
- Distribution pattern
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Recall initiation date
- Dec 4, 2018
- Initial firm notification
- Press Release
- Center classification date
- Dec 14, 2018