Published recall report · ImpurityUpdated · 7 yr 9 mo ago
Mylan Pharmaceuticals Inc. recall: 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.
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.
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
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.
- Producer
- Mylan Pharmaceuticals Inc.
- Brand
- VALSARTAN AND HYDROCHLOROTHIAZIDE
3084886
- Dates on pack
- Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
3093804
- Dates on pack
- Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
0303786323777
More detail
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
In the news
Reporting from news publishers. Follow the official notice for product advice.
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