FDAFDA · Food and drugs·Recall number D-1174-2018
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90
Published September 12, 2018 · Recall initiated: July 18, 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
- Avkare Incorporated
- Distributor
- Nationwide
- Lot
- Lots: 17325 Exp. 09/2018; 17856 Exp. 09/2018; 18396 Exp. 09/2018; 18702 Exp. 02/2019; 19020 Exp. 02/2019; 19222 Exp. 02/2019; 20030 Exp. 04/2019; 20381 Exp. 04/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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