Drug 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.
D-1049-2016
Product summary
- Event
- Event 74423
- Status
- Terminated
- Classification
- Class III
- Quantity
- 60 bottles (5 cases)
- Official record key
drug-enforcement:D-1049-2016
Official wording
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.
Code information: Lot #: 327B16002, Exp 12/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing