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Class IDrug recallTerminated

Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule recall

Recalled by MasterPharm LLC of South Richmond Hill, NY · FDA report 07/08/2020

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class I
Most serious
Status
Terminated
Closed 10/16/2023
Recall started
06/09/2020
Distribution
2 states

Reason for recall

Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.

Class I: A reasonable chance that using or being exposed to the product will cause serious health problems or death.

Recalled product

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.
Lot and code info
Lot #: 01-09-2020:13@8, Exp. 7/7/2020
Quantity
300 capsules
Recall number
D-1363-2020
Event ID
85839
Initiated by
Voluntary: Firm initiated

Where it was distributed

FL and MD

Recall timeline

  1. 06/09/2020Firm started the recall
  2. 06/26/2020FDA classified it as Class I
  3. 07/08/2020Published in the FDA enforcement report
  4. 10/16/2023FDA closed (terminated) the recall

More recalls from MasterPharm

Frequently asked questions

Why was Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule recalled?
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
What does Class I mean?
Class I is FDA's most serious recall category: a reasonable chance that using or being exposed to the product will cause serious health problems or death.
Where was the recalled product sold?
FL and MD
Is this recall still active?
The FDA lists the recall as terminated (closed 10/16/2023). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 07/08/2020 · Do not rely on openFDA to make decisions regarding medical care