Clinical Updates — Clinical Updates
FDA Alert: Oregon Compounding Centers, Inc (Creative Compounds) Recalls Avastin
Recall prompted by lack of sterility assurance
The US Food and Drug Administration (FDA) has just announced that Oregon Compounding Centers, Inc, also known as Creative Compounds, is voluntarily recalling certain unexpired sterile products due to lack of sterility assurance.
Recalled injectable ophthalmic products include:
- Avastin (bevacizumab)
- Lidocaine HCL (repkg-sterile) 4% solution
- Prednisolone sod phos 1% ophthalmic
- Procaine HCL (buff) 1% injectable
- Triesence (syringe-repkg) 8 MG/2.0 ML inj
- Vancomycin (syringe) 1 MG/0.1 ML inj
The FDA reports that Oregon Compounding Centers, Inc is issuing this voluntary recall following a recent inspection that identified an issue with sterility assurance. The pharmacy has not received any reports of product contamination or adverse events to date.
According to the FDA, all recalled products have a label that includes the Creative Compounds name as well as a lot number. The recalled products were made from July 1, 2014 through September 22, 2014, and were distributed to health care facilities, physicians, and patients in Oregon and Washington.
Please see the pharmacy's news release for a complete list of recalled products.
If you have any of the recalled products, you are advised to immediately discontinue use and return the recalled unexpired products. To return products or request assistance related to this recall, please call 503-685-6111 or 877-585-6111, Monday through Friday, between 9:30 AM and 1:00 PM or between 1:30 PM and 5:30 PM PDT.
To report an adverse event or side effect:
- Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.
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Published October 2014