Valsartan Tablets USP 320 mg recall: Impurity Out of Spec
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O…
Why was Valsartan Tablets USP 320 mg recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # G2017F NDC 68788-6882-9
- Product
- Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O…
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Quantity
- 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.
- Recall date
- August 29, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)