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| The United States: MasterPharm, LLC. issues voluntary nationwide recall of Finasteride Plus 1.25mg due to the presence of an undeclared antihypertensive drug (English only) |
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The US Food and Drug Administration (FDA) announces that MasterPharm, LLC. is voluntarily recalling one lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil was found when tested with an independent testing laboratory.
Consumption of undeclared minoxidil would be expected to result in low blood pressure, rapid heartbeat, and salt and water retention causing swelling. Consequently, patients may be at risk for developing heart failure or other heart damage. Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use. MasterPharm, LLC. has received 33 reports of increased heart rate, retention of water, dizziness and low blood pressure.
The product is a compounded drug for hair loss and is packaged in orange prescription bottles containing 30 capsules or blue prescription bottles containing 90 capsules. The affected Finasteride Plus 1.25mg lot includes the following 02-27-2020:04@11 and a Beyond Use Date of August 25, 2020. The product can be identified by the patient-specific labeled prescription bottles with product batch labels and a patient-specific prescription label. Finasteride Plus 1.25mg was distributed nationwide on a patient-specific prescription basis only.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmceutical product.
Ends/Tuesday, May 12, 2020
Issued at HKT 16:00
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