MasterPharm is voluntarily recalling 1 lot of Finasteride Plus 1.25 mg. capsules to the consumer level.
The capsules undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products, MasterPharm said in a press release. MasterPharm has received 33 reports of increased heart rate, retention of water, dizziness and low blood pressure.
Related: Pharma maker pulls weight loss drug over FDA concerns
“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,” MasterPharm said.
Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use.
Finasteride Plus is a compounded drug for hair loss and is packaged in orange prescription bottles containing 30 capsules or blue prescription bottles containing 90 capsules.
Related: Epilepsy, bipolar drug recalled due to contamination
The product was distributed nationwide on a patient-specific, prescription basis only, MasterPharm said. The affected Finasteride Plus 1.25 mg. lot number is 02-27-2020:04@11, and it has a Beyond Use Date of August 25, 2020.
Consumers should contact their physician or healthcare provider if they have experienced any problems related to taking the product.
Consumers that have the Finasteride Plus lot that is being recalled should stop using it and return it to MasterPharm via self-addressed packaging, which has been sent to all customers.
Consumers with questions can contact MasterPharm at (866) 630-5600 or recall@masterpharm.com.
Read more: More ranitidine recalled, plus another big drug recall
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