Teva Mold Contamination Problems Result in Recall for 2.5M Drug Vials, Shut Down of California Plant
Teva Pharmaceuticals is reportedly recalling 2.5 million vials of drugs and temporarily shutting down one of its manufacturing facilities, due to mold contamination and potential sterility problems.
While the Teva recalls have not been publicly announced, and no information has been released yet about the affected drugs, Bloomberg News reports that Teva officials acknowledged in emails that about 1 million vials of drugs recalled in February may experience problems, including some generic cancer medications, arthritis drugs, and others, as well as another 1.5 million vials recalled in July.
The recalls occurred after mold, caused by water leaks, was discovered in the air of the manufacturing areas of its Irvine, California production facility. In July, FDA inspectors found the company had left some water damage at the plant unrepaired, which may have contributed to the mold growth.
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The inspectors also found that the company failed to employ adequate procedures to keep workers from spreading mold and bacteria further throughout the facility. In addition, they found dirty benches in a room where factory workers change into their scrubs, and there was no company procedure for sanitizing them. FDA inspectors also reported that workers would wear their scrubs to the restroom and to take out the trash and would return to work without changing them.
Some equipment at the facility had not been tested for contamination since its installation 21 years ago, according to the reports.
The details from the investigations were uncovered by Bloomberg News through a Freedom of Information Act request.
Teva officials told Bloomberg in an email that they were taking extensive actions to address the FDA’s concerns and to minimize patient impacts, and the FDA indicates it has been closely monitoring the situation. Those actions include the recent shuttering of the plant while it undergoes a thorough review, Teva officials said.
The production plant has faced similar problems in the past when it received an FDA warning letter in 2009 regarding the production of the sedative Propofol. Teva dropped Propofol production in 2010.
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