Class III
Terminated
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.
This recall has been terminated (originally issued June 29, 2016).
- Company
- Prinston Pharmaceutical Inc
- Recall Initiated
- May 30, 2016
- Posted
- June 29, 2016
- Recall Number
- D-1049-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60 bottles (5 cases)
- Firm Location
- Cranbury, NJ, United States
- Official Source
- View on FDA website ↗
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
Nationwide
Lot / Code Info
Lot #: 327B16002, Exp 12/17
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