Reported Jun 29, 2016 · Terminated

Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical…

Prinston Pharmaceutical Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 · 2002 Eastpark Blvd · Cranbury, NJ · 08512-3514

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, Zhejiang 317024, China
  • Distributed bySolco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09
Lot codes and dates
    • Lot #: 327B16002
    • Exp 12/17
Amount recalled
60 bottles (5 cases)

Where it was sold

  • Nationwide

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 9, 2017 · Data as of Sep 19, 6:27 PM UTC

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