D-1049-2016 Class III Terminated
FDA drug recall D-1049-2016 was initiated by Prinston Pharmaceutical Inc on May 30, 2016 and is designated Class III. 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. The recall status is terminated (terminated Jun 9, 2017). Affected quantity: 60 bottles (5 cases).
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 29, 2016
- Initiation Date
- May 30, 2016
- Termination Date
- Jun 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 bottles (5 cases)
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 327B16002, Exp 12/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1049-2016
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026