Valsartan/HCTZ 160/12.5 mg Tablets recall: Impurity Out of Spec
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
Why was Valsartan/HCTZ 160/12.5 mg Tablets 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 # U01779; Exp. 04/30/2019
- Product
- Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
- Recalling firm
- NuCare Pharmaceuticals Inc
- Quantity
- N/A
- Distribution
- Distributed to three customers in Fl and CA
- Recall date
- August 15, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)