D-1107-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 29, 2018
- Initiation Date
- August 15, 2018
- Termination Date
- January 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 bottles consisting of 90 tables each bottle
Product Description
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.
Distribution Pattern
Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Code Information
Lot # G2017F NDC 68788-6882-9