Drug recall D-1049-2016
Product
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.
Reason for recall
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.
Lots and codes
Lot #: 327B16002, Exp 12/17
Recall details
- Recalling firm
- Prinston Pharmaceutical Inc, Cranbury, NJ
- Quantity
- 60 bottles (5 cases)
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 30, 2016
- Terminated
- June 9, 2017
Related products
- Irbesartan and Hydrochlorothiazide – drug information
- NDC 43547-331 Irbesartan and Hydrochlorothiazide · Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 · Solco Healthcare US, LLC
- NDC 43547-330 Irbesartan and Hydrochlorothiazide · Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 · Solco Healthcare US, LLC