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FDAMay 30, 2016drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

prinston pharmaceuticalprinston

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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