The Recall Desk
HighFDA (Drugs)·D-0189-2023·Announced 2023-02-01

Minoxidil injectable recalled due to lack of sterility assurance

Pharmacy Innovations is recalling Minoxidil 0.75% injectable due to insanitary facility conditions identified during FDA inspection that could compromise product sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II drug recall with no reported illnesses or injuries. However, the product is an injectable with documented lack of sterility assurance due to facility insanitary conditions, constituting a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Pharmacy Innovations is recalling Minoxidil 0.75% (1.5ML vial) Injectable, a prescription-only medication, distributed nationwide in the USA.

The FDA inspection of Pharmacy Innovations' facility revealed insanitary conditions that compromise assurance of sterility. Lack of sterility in injectable medications poses a potential risk of microbial contamination and infection.

Patients and healthcare providers in possession of this product should not use it. Contact your pharmacy or Pharmacy Innovations for return instructions and further guidance regarding this recall.

The recalled product

Product
Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer
Pharmacy Innovations
Category
Drug — Injectable Pharmaceutical
Hazard
  • lack-of-sterility
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • t20221011@36

Distribution

Distributed nationwide across the United States.

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