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Class II · ModerateRecall completed

Irbesartan

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot number331B18009
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byZhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 foreign manufacturer
Brand nameIRBESARTAN
Generic nameIRBESARTAN
Active ingredient(s)IRBESARTAN
Distributed by / forSolco Healthcare US, LLC Cranbury, NJ 08512
NDC43547-376-09
Show the full FDA record
Full product labelIrbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
Recalling firmPrinston Pharmaceutical Inc
DistributionNationwide
Quantity19800 bottles
Recall initiated2019-01-18
Report date2019-02-06
Recall completed—
Recall numberD-0409-2019
ClassificationClass II
FDA statusCompleted
Origin on fileSomerset NJ United States

Related

Irbesartan recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.