Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot # G2017F NDC 68788-6882-9
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 9 bottles consisting of 90 tables each bottle
- Distribution pattern
- Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Timeline
- Recall initiated
- 2018-08-15
- FDA classified
- 2018-08-17
- Posted by FDA
- 2018-08-29
- Terminated
- 2019-01-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1107-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.