FDAFDA · Food and drugs·Recall number D-1049-2016
Irbesartan 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.
Published June 29, 2016 · Recall initiated: May 30, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Prinston Pharmaceutical Inc
- Distributor
- Nationwide
- UPC
- 0343547331030
- Lot
- Lot #: 327B16002, Exp 12/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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