Reported Feb 6, 2019 · Completed
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical…
Prinston Pharmaceutical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Prinston Pharmaceutical Inc · 700 Atrium Dr · Somerset, NJ · 08873-4107
Is this the product you have?
- Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5
- mg Rx Only Manufactured byZhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024
- China Distributed bySolco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03
- Lot codes and dates
- 327A18001 327A18002
- Amount recalled
- 32692 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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