FDAFDA · Food and drugs·Recall number D-0984-2018
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19
Published August 1, 2018 · Recall initiated: July 16, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Lot
- Lot Numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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