RecallDepth
Class II Terminated

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

Company
Preferred Pharmaceuticals, Inc.
Recall Initiated
August 15, 2018
Posted
August 29, 2018
Recall Number
D-1107-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
9 bottles consisting of 90 tables each bottle
Firm Location
Anaheim, CA, United States

Reason for Recall

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

Distribution

Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.

Lot / Code Info

Lot # G2017F NDC 68788-6882-9

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