Cecil-based generic drug giant Mylan Inc. is recalling a total of 1.45 million bottles of four different medications because the active ingredients were not made according to good manufacturing practices, the Food and Drug Administration said Friday.
The largest recall covers nearly 1 million bottles of the antibiotic ciprofloxacin. The others include about 28,000 bottles of the anticonvulsant and mood stabilizer lamotrigine, and roughly 300,000 bottles of amlodipine and about 175,000 bottles of a combination pill with amlodipine and benazepril, both used to lower blood pressure.
The prescription medications were distributed nationwide and in Puerto Rico.
The recalls, which appeared in the FDA's enforcement report this week, were initiated Sept. 13, according to the report.
FDA spokesman Chris Kelly said patients taking any of the drugs should not stop using them until first consulting with their health care provider.
In an email statement issued Friday through an attorney, Mylan said the active ingredients were supplied by Smruthi Organics Ltd., a raw materials maker in India, and that the voluntary recalls were due to manufacturing compliance issues identified at Smruthi.
"No risk to patient safety has been identified," Mylan said in the statement. "Mylan will continue to monitor and evaluate any reports received."
Mylan added that it had completed an investigation regarding the compliance issues at Smruthi and "has taken appropriate steps."
Mylan conducted a similar recall in Canada this spring.
Consumers with questions about the recalls should contact the FDA's division of drug information toll-free at 1-855-543-3784. For lot numbers of the affected drugs, visit www.fda.gov and click "Enforcement Report" on the home page.
Patricia Sabatini: email@example.com or 412-263-3066.