Risk Management
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Pine Pharmaceuticals Announces Voluntary Recalls, Including Avastin
October 4, 2023
Dear OMIC Insureds:
According to a bulletin from the American Academy of Ophthalmology(AAO), Pine Pharmaceuticals elected to issue a voluntary recall for specific lots of repackaged bevacizumab (Avastin). OMIC recommends you review the AAO bulletin (which includes letters from the manufacturer) and consider the following, while continuing to monitor the situation:
Since there are no reports of harm to patients, there is not an immediate need to notify patients who have received prior doses of Avastin prepared by Pine Pharmaceuticals. However, if the situation changes, or if it is part of your drug recall response plan to notify patients regardless of reports of harm, you should proceed with identifying and notifying affected patients. Healthcare professionals should immediately check their medical supplies, quarantine any drugs intended to be sterile and prepared by Pine Pharmaceuticals, and not administer or provide them to patients. Since this may result in a shortage of the drug, you should consider alternative sources that adhere to proper quality standards.
If you have questions about this topic or would like to have a confidential risk management consultation, please email riskmanagement@omic.comor call the Risk Management Hotline at 1-800-562-6642 and enter 4 for Risk Management.
Sincerely,
Michelle Pineda, MBA
OMIC Risk Manager
