FDAFDA · Food and drugs·Recall number D-1145-2018
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
Published September 5, 2018 · Recall initiated: August 17, 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 · Letter
Recall details
- Manufacturer
- Torrent Pharma Inc.
- Distributor
- Nationwide USA
- Lot
- Batch: BBY4D004, BBY4E001, BBY4D001, BBY4D002, BBY4D003
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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