FDA recall D-1107-2018

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-08-15

Report date

2018-08-29

Termination date

2019-01-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1107-2018