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Class III · Lower riskRecall completed

Irbesartan And Hydrochlorothiazide

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 327B16002, Exp 12/17
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

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

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., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512 foreign manufacturer
Brand nameIRBESARTAN AND HYDROCHLOROTHIAZIDE
Generic nameIRBESARTAN AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, IRBESARTAN
Distributed by / forSolco Healthcare U.S., LLC, Cranbury, NJ 08512
NDC43547-331-09
Show the full FDA record
Full product labelIrbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.
Recalling firmPrinston Pharmaceutical Inc
DistributionNationwide
Quantity60 bottles (5 cases)
Recall initiated2016-05-30
Report date2016-06-29
Recall completed2017-06-09
Recall numberD-1049-2016
ClassificationClass III
FDA statusTerminated
Origin on fileCranbury NJ United States

Related

Hydrochlorothiazide recallsIrbesartan 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.