Reported Feb 6, 2019 · Completed
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai,…
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 Tablets 300
- mg 90 count Rx only Manufactured byZhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai
- Zhejiang 317024 China Distributed bySolco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
- Lot codes and dates
- 331B18009
- Amount recalled
- 19800 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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