Recalls / Class I
Class ID-1363-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.
- Affected lot / code info
- Lot #: 01-09-2020:13@8, Exp. 7/7/2020
Why it was recalled
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Recalling firm
- Firm
- MasterPharm LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11502 Liberty Ave Fl 2, N/A, South Richmond Hill, New York 11419-1902
Distribution
- Quantity
- 300 capsules
- Distribution pattern
- FL and MD
Timeline
- Recall initiated
- 2020-06-09
- FDA classified
- 2020-06-26
- Posted by FDA
- 2020-07-08
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1363-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.