Drugs

Teva Shuts Plant, Recalls Drugs Over Sterility

Teva Pharmaceuticals has temporarily stopped production at its Irvine, CA manufacturing facility after a recent FDA inspection cited manufacturing concerns and the company recalled 2.5 million vials of drugs that may not be sterile. The drug vials recalled include those for treating cancer, arthritis, schizophrenia and a muscle relaxer used during intubation, Bloomberg news reported.

Teva recalled almost a million vials in February after detecting mold in the air. A subsequent recall occurred in July during an FDA inspection discovered unrepaired water damage that may have led to the mold growth, according to inspection documents obtained by Bloomberg.

An FDA statement in July said one lot of topotecan injection (4mg/4mL) was recalled due to the presence of particulate matter. An agency statement says the nationwide recall to the retail/institutional level was initiated based on a complaint from a pharmacy after a single glass particle was observed inside one vial. The notice says that after further examination of the complaint sample, two other particulates were found — one gray silicone particle and one translucent, colorless cotton fiber. The drug is indicated for treating patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy and for patients with small-cell lung cancer platinum-sensitive disease who progressed at least 60 days after initiation of first-line therapy. It also is indicated for treating patients with stage IV-B recurrent or persistent cervical cancer that is not amenable to curative treatment, in combination with cisplatin.

According to the inspection documents, FDA investigators said benches where workers changed into their scrubs were visibly dirty and that the company’s protocols didn’t include any procedure for sanitizing them. In addition, workers wore their scrubs outside to take out the trash or to use the restroom, and they were not changed when they re-entered the manufacturing area. Additionally, Teva could not document that equipment used to ensure sterility and test for harmful organisms worked properly since it was installed 21 years ago, despite a change in how testing was conducted.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome