FDAFDA · Food and drugs·Recall number D-1037-2018
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
Published August 15, 2018 · Recall initiated: July 30, 2018
Status when published: Terminated — 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 · Letter
Recall details
- Manufacturer
- NuCare Pharmaceuticals Inc
- Distributor
- Distributed to three customers in Fl and CA
- Lot
- Lot # U01779; Exp. 04/30/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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