Recalls / Class III
Class IIID-1049-2016
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.
- Brand name
- Irbesartan And Hydrochlorothiazide
- Generic name
- Irbesartan And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Irbesartan
- Route
- Oral
- NDCs
- 43547-330, 43547-331
- FDA application
- ANDA203072
- Affected lot / code info
- Lot #: 327B16002, Exp 12/17
Why it was recalled
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.
Recalling firm
- Firm
- Prinston Pharmaceutical Inc
- Manufacturer
- Solco Healthcare US, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2002 Eastpark Blvd, N/A, Cranbury, New Jersey 08512-3514
Distribution
- Quantity
- 60 bottles (5 cases)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-30
- FDA classified
- 2016-06-23
- Posted by FDA
- 2016-06-29
- Terminated
- 2017-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1049-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.