Recalls / Class II
Class IID-0365-2019
Product
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
- Brand name
- Valsartan And Hydrochlorothiazide
- Generic name
- Valsartan And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Valsartan
- Route
- Oral
- NDCs
- 65862-547, 65862-548, 65862-549, 65862-550, 65862-551
- FDA application
- ANDA202519
- Affected lot / code info
- Lot # HRSA17033-A, exp. date 10/2020 Lot # HRSA17034-A, exp. date 10/2020 Lot # HRSA17035-A, exp. date 10/2020 Lot # HRSA17036-A, exp. date 10/2020 Lot # HRSA17037-A, exp. date 10/2020
Why it was recalled
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.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 23,016 bottles
- Distribution pattern
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2018-12-31
- FDA classified
- 2019-01-14
- Posted by FDA
- 2019-01-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0365-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.