Recall: D-0367-2019

Class II - Potentially Harmful

Class IIClassification

2018-12-31Initiated

OngoingStatus

Aurobindo Pharma USA Inc.Firm

Product

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.

Reason

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Distribution

Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.