Valsartan/HCTZ 160 mg/12.5 mg tablet recall: Impurity Out of Spec
Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Why was Valsartan/HCTZ 160 mg/12.5 mg tablet 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 # B0318652-070617; Exp. 07/18
- Product
- Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 4 HDPE 90-count bottles (360 tablets)
- Distribution
- Product was distributed to 3 medical facilities in Florida.
- Recall date
- August 8, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)