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

Recall date

May 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1049-2016

FDA classification

Class III

Brand / firm

Prinston Pharmaceutical Inc

Sold / distributed

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.