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 Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.
Lot numbers, UPCs & expiration codes
Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623
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-0326-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 4, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 232,180 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF)
Original FDA data
Every field from FDA enforcement report D-0326-2019, 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: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0326-2019
- Classification
- Class II
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF)
- Product quantity
- 232,180 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 Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.
- 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