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 #: 327B16002Exp 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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