March 20, 2019
Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. Prinston is only recalling lots of Irbesartan-containing products that contain N- nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
N-nitrosodiethylamine (NDEA) is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.
Irbesartan and Irbesartan HCTZ are used to control high blood pressure and for the treatment of heart failure.
What is being recalled?
- Irbesartan and Irbesartan HCTZ manufactured by Prinston Pharmaceuticals dba Solco Healthcare. Only specific lot numbers are being recalled.
- You can find general information regarding this recall on the FDA website:
What do I need to know?
- Express Scripts will mail letters to patients who have received medication impacted by the recall.
- The Food and Drug Administration has stated that patients who have the recalled medicine should continue taking it until they have a new supply unless otherwise directed by their healthcare provider, as the risk of harm to the your health may be higher if the treatment is stopped immediately without any alternative treatment.
- Please consult with your prescriber for guidance on continuing to take this medication or if you should obtain a new prescription for an alternative therapy.
- If you and your prescriber decide you should continue to take the medication on hand, your next fill will be processed using medication that is not part of any existing recall.
- If you choose to stay on this therapy but need to obtain a fresh supply and it is not time for your next refill, please call us at the toll free number on your prescription bottle to request an early refill. Your order will be filled with medication that is not part of any existing recall.
Why was this medication recalled?
- This voluntary recall is being issued because an impurity, N-Nitrosodiethylamine (NDEA), was detected in the recalled lots. N-nitrosodiethylamine (NDEA) is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes and has been classified as a probable human carcinogen.
- Any suspected adverse events that may be related to the use of these products should be reported to your doctor. You can also report adverse events that may be related to this recall to FDA's Med Watch Program either online, by regular mail or by fax.
- Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
- Regular Mail: Use postage-paid, pre-addressed Form FDA 3500B available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to the address on the pre-addressed form.
- Fax: 1-800-332-0178 (toll free)
Last updated: March 13, 2020