Drug recall
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai…
FDA recall event 74423 · Class III · Prinston Pharmaceutical Inc
Key facts
| Event ID | 74423 |
|---|---|
| Recall numbers | D-1049-2016 |
| Recalling firm | Prinston Pharmaceutical Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | May 30, 2016 |
| Report date | Jun 29, 2016 |
| Termination date | Jun 9, 2017 |
| City | Cranbury |
| State | NJ |
| Country | United States |
| FEI number | 3009298353 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: