Unique Pharmaceuticals, Ltd., has recalled 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 the U.S. Food and Drug Administration’s (FDA) 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 says it has received no reports of injury or illness associated with the use of its sterile preparations. 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: firstname.lastname@example.org
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm/ Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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