FDAFDA · Food and drugs·Recall number D-1107-2018
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
Published August 29, 2018 · Recall initiated: August 15, 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
- Preferred Pharmaceuticals, Inc
- Distributor
- Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
- Lot
- Lot # G2017F NDC 68788-6882-9
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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