FDA Drug recall D-1049-2016
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, L…
- FDA Drug
- Class III
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class III recall of Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, L… by Prinston Pharmaceutical, citing 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 contain….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1049-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-30 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Prinston Pharmaceutical |
| Distribution | US |
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
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.
Identifiers
| ndc | 43547-330-03 |
|---|---|
| ndc | 43547-330-09 |
| ndc | 43547-330-50 |
| ndc | 43547-331-03 |
| ndc | 43547-331-09 |
| ndc | 43547-331-50 |
| code_info | Lot #: 327B16002, Exp 12/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1049-2016%22
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