June 2020 FDA Recall Drug by Masterpharm Llc
D-1363-2020 - Super-potent Drug

This Class I drug recall was voluntarily initiated by Masterpharm Llc on June 9, 2020 for the product Drug. The FDA reported the reason for recall as super-potent drug. The product was distributed in FL and MD and the recall is currently terminated.

Recall Number: D-1363-2020

Reason for Recall
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Initiated
06-09-2020
Reported
07-08-2020
Quantity
300 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85839
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MasterPharm LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL and MD
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : 01-09-2020:13@8, Exp. 7/7/2020