PHILADELPHIA (CN) - Microscopic pieces of glass in the generic version of a cholesterol drug subject to a federal recall cut up a Delaware man's urinary tract, he claims in court.
The Oct. 1 complaint filed in the Philadelphia Court of Common Pleas alleges that Calvin Johnson had a kidney stone and blood in his urine after taking atorvastatin, the generic version of Lipitor manufactured by Ranbaxy Pharmaceuticals.
Johnson claims that his injuries
During production, Ranbaxy's negligence led to the incorporation of a glass contaminant in generic atorvastatin, making the "product defective and unsafe for human ingestion," the complaint states.
Johnson says Ranbaxy also breached to its duty to inspect and to produce a pharmaceutical product safe for human consumption.
The lawsuit comes nearly two years after the Food and Drug Administration a voluntary recall by Ranbaxy of certain shipments of its 10, 20 and 40-mg a
"The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, are being recalled due to possible contamination with very small glass particles similar to the size of a grain of sand (less than 1 mm in size)," according to the announcement.
Ranbaxy said it halt further production of the drug pending a full investigation into the cause of the contamination.
The FDA meanwhile found the possibility "extremely low" that patients would experience adverse health problems related to the recalled atorvastatin.
"Patients who have the recalled medicine can continue taking it unless directed otherwise by their physician or health care provider," the Nov. 30, 2012, release states. "To date, FDA hasn't received any reports of injury."
The FDA granted Ranbaxy an exclusive license to manufacture the generic cholesterol-reduction drug in 2011, CBS News reported
India-based Ranbaxy has offices and a research laboratory in Princeton, N.J., the address to which Newark, Del.-based Johnson addressed his complaint.
Johnson and his wife, Diana, seek $50,000 in damages. They are represented by Leonard Parks. The Office of Parks & Associates did not return a call seeking comment.
Ranbaxy reached a $2.3 million settlement with the Oregon Department of Justice this past July in connection with a lawsuit alleging that it sold unsafe generic prescription drugs to consumers.
The company also pleaded guilty in May 2013 to seven felonies and agreed to pay $500 million to settle claims that it made adulterated drugs in India and distributed them in the United States.
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