Leiter’s Compounding Pharmacy announced a voluntary recall of three lots of sterile products due to concerns with sterility assurance with its independent testing laboratory.
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Avella Specialty Pharmacy announced a voluntary recall of Bevacizumab 1.25mg/0.05mL PF and Vancomycin PF (BSS) 1% due to lack of sterility assurance.
Due to lack of sterility assurance, Clinical Specialties is voluntarily recalling all lots of sterile products that were repackaged and distributed by the pharmacy. This recall follows the company’s recall of Avastin unit dose syringes on March 18th.
After reports surfaced of five intraocular infections at a physician’s office, Clinical Specialties is undertaking a voluntary recall of Avastin unit dose syringes. The sterile syringes were being used solely for an off-label indication by an ophthalmologist for macular degeneration.
The FDA has confirmed that a counterfeit version of Roche’s Altuzan 400mg/16mL (bevacizumab), an injectable cancer medication, found in the US contains no active ingredient.
The FDA is warning healthcare professional about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the U.S.
The FDA commissioner, Margaret A. Hamburg, MD, has revoked the approval of Avastin (bevacizumab; Genentech) for the treatment of breast cancer after concluding that the drug has not been shown to be safe and effective for that use.
The FDA is alerting healthcare professionals that repackaged intravitreal injections of Avastin (bevacizumab; Genentech) have caused a cluster of serious eye infections in the Miami area.
Genentech announced that during a FDA hearing, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated, first-line HER2-negative metastatic breast cancer.
The FDA has granted a hearing to allow Genentech the opportunity to present its views on why Avastin (bevacizumab) should remain FDA-approved for metastatic breast cancer.