Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03
Drug Recall
Official source record
- Recall number
- D-0413-2019
- Event ID
- 81910
- Classification
- Class II
- Status
- Completed
- Recalling company
- Prinston Pharmaceutical Inc
- Reason for recall
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Report date
- February 6, 2019
- Recall initiation date
- January 18, 2019
- Termination date
- Not terminated as of this source record
- Distribution pattern
- Nationwide
Drug product identifiers
- Manufacturer
- Solco Healthcare US, LLC
- Brand name
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Generic name
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Substance names
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Product NDCs
- 43547-330; 43547-331
- Package NDCs
- 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50
- Route
- ORAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to the FDA, this recall's status is "Completed." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
