MasterPharm LLC
FDA issued a warning letter to MasterPharm LLC (South Richmond Hill, NY) following a May–June 2020 inspection that revealed serious manufacturing deficiencies at the compounding pharmacy. The firm's Finasteride Plus capsules were found to contain super-potent finasteride (1.49 mg vs. labeled 1.25 mg) and undeclared minoxidil at 127.86 mg per capsule, triggering 74 adverse-event MedWatch reports and a voluntary recall. FDA cited the drug products as both adulterated (insanitary conditions, cross-contamination, incorrect strength, undeclared ingredient) and misbranded (false/misleading labeling), and warned that failure to correct violations could result in seizure or injunction.
Flagged claims (2)
labels for your Finasteride Plus oral capsules did not disclose that this product contained the antihypertensive drug, minoxidil, in an amount that greatly exceeds the amount found in FDA approved products
analyses showed that your Finasteride Plus oral capsules, with a labeled strength of 1.25mg, contained an average 1.49 mg per oral capsule
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
FDA acknowledges that your firm voluntarily ceased dispensing drug products in capsule dosage form until corrective actions are implemented and, on July 2, 2020, voluntarily recalled compounded products within expiry that were prepared by (b)(4) of your firm's technicians with initials "(b)(6), (b)(7)(C)." from (b)(4), due to cross contamination with other drug products, super-potency issues, and lack of processing controls.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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