CHARLOTTE AMALIE — The Virgin Islands Health Department said that Lupin Pharmaceuticals has voluntarily recalled batches of two blood pressure drugs last month because they may contain high levels of a substance that could cause cancer.
“The recall is due to the potential presence of a probable human carcinogen based on results from laboratory tests,” according to Health.
Health Department spokesperson Rebekah Kubla did not respond questions as to why the department waited more than three weeks to notify the public of the recalled drug.
According to the statement, Lupin has received no reports of illness that appear to relate to this issue, but is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the U.S. “out of an abundance of caution.
“Lupin advises patients who are prescribed the drugs to continue taking their medication and contact their pharmacist, physician or medical provider for advice ‘regarding an alternative treatment,’ ” the Health Department said in the prepared statement.
The company, in an Oct. 14, statement from its Baltimore headquarters said the earliest shipment date of the drug was Sept. 8 and urged patients to discontinue taking the medication and to report any adverse reactions to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
• Complete and submit the report at https://www.fda.gov/safety/medwatch-fda-safetyinformation-and-adverse-event-reporting-program/reporting-serious-problems-fda
• For regular mail or fax visit https://www.fda.gov/safety/medical-product-safetyinformation/medwatch-forms-fda-safety-reporting or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178.
The company also said it notified consumers, wholesalers, distributors, and retailers, but those with questions regarding the recall should contact Inmar Rx Solutions, Inc. at 855-769-3988 from 10 a.m, to 6 p.m., Monday through Friday.
For reimbursement, residents should have the recalled lots returned to Inmar Rx Solutions, Inc. The lot number can be found on the side of the bottle label.
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