Recalls / Class II
Class IID-0411-2019
Product
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03
- Brand name
- Irbesartan And Hydrochlorothiazide
- Generic name
- Irbesartan And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Irbesartan
- Route
- Oral
- NDCs
- 43547-330, 43547-331
- FDA application
- ANDA203072
- Affected lot / code info
- 327A18001 327A18002
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
- Prinston Pharmaceutical Inc
- Manufacturer
- Solco Healthcare US, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 700 Atrium Dr, N/A, Somerset, New Jersey 08873-4107
Distribution
- Quantity
- 32692 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-01-18
- FDA classified
- 2019-01-27
- Posted by FDA
- 2019-02-06
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0411-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.