Irbesartan and Hydrochlorothiazide Tablets — Class III drug recall D-1049-2016
Terminated recall by Prinston Pharmaceutical Inc, reported 2016-06-29, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case labe
| Recall number | D-1049-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prinston Pharmaceutical Inc, Cranbury, NJ, United States |
| Recall initiated | 2016-05-30 |
| Classified | 2016-06-23 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2017-06-09 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 43547-0330, 43547-0330-03, 43547-0330-09, 43547-0330-50, 43547-0331, 43547-0331-03, 43547-0331-09, 43547-0331-50 |
| Lot numbers | 12/17, 327B16002 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1049-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.