Recall -- Firm Press Release
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Unique Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all Sterile Compounded Preparations Within Their Expiry Period Due to a Lack of Sterility Assurance
FOR IMMEDIATE RELEASE - July 19, 2014 - Unique Pharmaceuticals, Ltd., ("Unique" or "the Company") today 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 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.
Consumers or health care providers with questions regarding this recall may contact Unique by phone at [888-339-0874] from the hours of 9 a.m to 5 p.m. CST Central Time, Monday through Friday, or at the following e-mail address: email@example.com
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.
- Online: www.fda.gov/medwatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.