Unique Pharmaceuticals, Ltd., has announced a voluntary nationwide recall of all sterile drug preparations associated with the outsourcing facility and 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. The FDA contends they present a lack of sterility assurance observed during recent FDA inspections.
The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products.
When sterile products are compromised, patients are at risk for serious and possible life-threatening infections. 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 act of caution.
The recall includes all sterile compounded preparations that Unique has supplied to its customers within expiry dates. Non-sterile preparations are not affected by this recall. The affected products were distributed in syringes, vials, and bags.
The preparations covered under this recall were distributed nationwide. Health care providers should stop using all lots of sterile products prepared by Unique until further notice and return unexpired products to the Company.
- Unique will be contacting customers by phone, fax, mail, or personal visits informing them to return the products to the Company.
- Consumers or Health Care Providers with questions regarding this recall may contact Unique Pharmaceuticals via telephone at 888-339-0874, from the hours of 9 a.m. to 5 p.m. CST Central Time, Monday through Friday. They can also be contacted using the following e-mail address: email@example.com
- 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
- 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.
- This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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