Sterile drug products by Bella Pharmaceuticals: Recall — lack of sterility assurance.
ISSUE:
Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
BACKGROUND:
The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release.
RECOMMENDATION:
Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall should stop using it and contact the company. To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.
Click here to read the MedWatch safety alert, along with a link to the current press release.
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(Source: FDA MedWatch)
