FDAFDA · Food and drugs·Recall number D-1021-2018
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Published August 8, 2018 · Recall initiated: July 17, 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
- RemedyRepack Inc.
- Distributor
- Product was distributed to 3 medical facilities in Florida.
- Lot
- Lot # B0383153-122917; Exp. 12/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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