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 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Lot numbers, UPCs & expiration codes
Lot numbers: 3084889 3084890 3093803
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-0331-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 4, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 19,352 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF)
Original FDA data
Every field from FDA enforcement report D-0331-2019, 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: 3084889 3084890 3093803
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0331-2019
- Classification
- Class II
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF)
- Product quantity
- 19,352 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 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), 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