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
Reported: August 29, 2018 Initiated: August 15, 2018 #D-1107-2018
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.
Details
- Recalling Firm
- Preferred Pharmaceuticals, Inc
- Units Affected
- 9 bottles consisting of 90 tables each bottle
- Distribution
- Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
- Location
- Anaheim, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Preferred Pharmaceuticals, Inc. Units affected: 9 bottles consisting of 90 tables each bottle.
Why was this product recalled? ▼
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 29, 2018. Severity: Moderate. Recall number: D-1107-2018.
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