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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 59 products in this recall →Related recalls
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