Unique Pharmaceuticals Sterile Drug Preparations


Recall Number: #98a6771660
Date Published: July 17, 2014
Manufacturer: Unique Pharmaceuticals, Ltd.

Hazards

Serious and possible life-threatening infections

Summary by USRecalls.org

Unique Pharmaceuticals has issued a voluntary nationwide recall of all sterile drug preparations associated with the outsourcing facility and that that are still within the expiration date on the products. Upon inspection the FDA had concerns "a lack of sterility assurance observed". This could result in serious infection and possible in cases life-threatening infections.

FDA Official Description

Unique Pharmaceuticals, Ltd. 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.

Products Affected

Products recalled include all sterile compounded preparations distributed nationwide in syringes, vials, and bags. Lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products.

What do I do next?

Consumers or Providers with questions about this recall should contact Unique Pharmaceuticals toll free at 888-339-0874, Monday through Friday 9 a.m. to 5 p.m. Central or by email recall@upisolutions.com