Unique Pharmaceuticals, an FDA-registered 503 B compounding pharmacy outsourcing facility dedicated to improving quality of life and providing trusted compounded preparations for clinics, hospitals and surgery centers throughout the US, announced a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products.
Unique is initiating the recall due to US FDA's concerns associated with Unique's compounding facilities and compounding processes that FDA contends present a lack of sterility assurance and were observed during recent FDA inspections.
In the event a sterile product is compromised, patients are at risk for serious and possible life-threatening infections. To date, Unique has received no reports of injury or illness associated with the use of its sterile preparations. Patient safety is Unique's highest priority, and Unique has proceeded with this voluntary action out of an abundance of caution.
The recall includes all sterile compounded preparations that Unique has supplied to its customers within expiry. Non-sterile preparations are not affected by this recall. The affected products were distributed in syringes, vials, and bags.
The preparations covered by this recall were distributed nationwide. Until further notice, health care providers should stop using all lots of sterile products prepared by Unique that are within their expiry period and return them to the Company.
Unique will be notifying customers by phone, fax, mail, or personal visits to return the products to the Company.
Adverse reactions or quality problems experienced with the use of any Unique's preparations may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.