OCT 10, 2014
U.S. Food and Drug Administration
Comprehensive Ophthalmology, Retina/Vitreous
Oregon Compounding Centers is voluntarily recalling a number of sterile products, including several lots of Avastin injection, due to sterility concerns. The recall includes only product distributed in Oregon and Washington.
The company, known as Creative Compounds, has received no reports of product contamination or adverse events to date, but is issuing the recall out of an abundance of caution following a recent inspection that identified an issue with sterility assurance.
All recalled products are labeled with the Creative Compounds name as well as a lot number, and were made from July 1, 2014 through Sept. 22, 2014, and distributed to health care facilities, physicians, and patients in Oregon and Washington. In addition to 1.25 mg bevacizumab, the recall includes:
CEFTAZIDIME (SYRINGE) 2.25/0.1ML INJECTABLE
DEXAMETHASONE (AS SOD PHOS) 24 MG/ML INJECTABLE
EPINEPHRINE/WATER (PF) 1:1000 INJECTABLE
GANCICLOVIR (PF) 2MG/0.1ML INJECTABLE
GENTAMICIN SULFATE 100MG/1000ML IRRIGATION
HYALURONIDASE 240U/ML INJECTABLE
LIDOCAINE HCL (REPKG-STERILE) 4% SOLUTION
TOBRAMYCIN 480MG/1000 ML IRRIG
TRIESENCE (SYRINGE-REPKG) 8MG/2.0ML INJ
VANCOMYCIN (SYRINGE) 1MG/0.1ML INJ
The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy. Find a complete list of recalled product online.
The company advises physicians to discontinue use immediately and return the recalled unexpired products. To return product or request assistance related to this recall, call (503) 685-6111 or (877) 585-6111, Monday through Friday, from 9:30 a.m. to 1 p.m. and 1:30 to 5:30 p.m. PDT.
Adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting Program:
- Submit the report online
- Download form to mail or fax
- 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