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

FDA recall notice · announced August 29, 2018 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Notes

Distribution: Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Lot/code information: Lot # G2017F NDC 68788-6882-9
Quantity: 9 bottles consisting of 90 tables each bottle
Status: Terminated
Products in this recall event:
- 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 (D-1107-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.