Stephen S. Laddy
Chief Executive Officer
MasterPharm LLC
115-02 Liberty Avenue, Suite 200
South Richmond Hill , NY 11419-1902
United StatesFEI 3005734706Issued Jul 19, 2021Division of Pharmaceutical Quality Operations I
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005734706.
Violations0
Issue DateJul 19, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
MasterPharm LLC
Location
Stephen S. Laddy
Chief Executive Officer
MasterPharm LLC
115-02 Liberty Avenue, Suite 200
South Richmond Hill , NY 11419-1902
United States
FEI Number
3005734706
Country
United States
Issue Date
July 19, 2021
Issuing Office
Division of Pharmaceutical Quality Operations I
Product Type
Drugs
Status
Open
Summary
MasterPharm LLC, a compounding pharmacy in New York, was warned for producing adulterated drug products with serious deficiencies in manufacturing practices that put patients at risk. FDA inspectors found that the company's Finasteride Plus capsules contained an average of 1.49 mg per capsule when labeled as 1.25 mg, and the facility had inadequate processing controls that resulted in cross-contamination and super-potency issues affecting 74 patients who reported adverse events. The company had voluntarily ceased dispensing capsule products and recalled compounded products due to these quality failures.
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