All Ameridose LLC drugs recalled after sterility testing problems
Ameridose recalls all drugs after FDA finds problems with its sterility testing
10/31/2012 5:47 PM
By Chelsea Conaboy, Liz Kowalczyk and Todd Wallack, Globe Staff
Ameridose LLC, sister company to the Framingham pharmacy whose drugs have been implicated in hundreds of fungal infections and 28 deaths, agreed to recall all its products Wednesday after federal investigators identified shortcomings in testing procedures, raising concerns that a shortage of sterile injectable drugs will become more severe.
“During the course of its on-going inspection of our facility,” the Westborough company said in a press release, the US Food and Drug Administration “has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.”
The company, which supplies thousands of hospitals and other health providers nationally, said it issued the recall voluntarily and had not received any reports of illness.
“Neither Ameridose nor the FDA has identified impurities in any Ameridose products,” the statement said. “Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA’s recommendations.”
Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said that during inspections of Ameridose’s production facility, investigators did not find “an adequate assurance of sterility in the manufacturing of their sterile products.’’
In a telephone interview, she said the recall was precautionary and that the agency “is not aware of any reports of patient infection.’’
Woodcock said the agency believes the recall will be large, and is concerned that it will worsen an existing shortage of sterile injectable drugs. She said the FDA is working with other manufacturers to try to help them ramp up production of drugs that could be difficult for hospitals and doctors to find as a result of the recall.
Ameridose shares owners with New England Compounding Center, the Framingham company that prepared steroid injections blamed for the outbreak of meningitis and joint infections around the country. Ameridose had agreed with Massachusetts regulators to suspend operations earlier this month while authorities investigated its operations, but the company has been adamant that allegations against New England Compounding were not reflective of any problems with the sterility of Ameridose products.
The state Department of Public Health said in a statement that to date, its joint investigation with the FDA has found no evidence of contaminated products made by Ameridose. It said the company’s agreement to suspend operations, which expires Monday, “is under review.”
The Massachusetts Hospital Association said the recall “will exacerbate an already troubling shortage of medications” caused by the shutdown of New England Compounding and temporary closure of Ameridose. And it said it’s now unclear “when, or even if, Ameridose will resume operations.”
Steroid injections produced and shipped by New England Compounding since May 21 have been linked to 377 infections, all but nine resulting in meningitis, the Centers for Disease Control and Prevention said Wednesday.
State and federal regulators have said inspectors found multiple sources of possible contamination in or near the pharmacy’s clean rooms and that injections had been shipped to customer days before the pharmacy’s own sterility tests had been complete.
Regulators have found similar problems with Ameridose in the past. A 2008 FDA inspection noted several issues, including that the company did not fully test all the lots of its drugs and shipped some lots before receiving the sterility test results. Shortly afterward, Ameridose recalled a painkiller because it was too potent.
Separately, a group purchasing company, Novation LLC of Irving, Texas, told customers earlier this year it planned to sever its ties with Ameridose at the end of this month because of concerns about the company’s quality controls. The companies agreed to extend their partnership only after Ameridose sued Novation.
Several past Ameridose employees also told the Globe recently they had concerns about the company’s safety procedures.
Ameridose said it was notifying customers by fax and arranging for return of the products. Customers with questions were directed to call 888-820-0622 during business hours.
Chelsea Conaboy can be reached at firstname.lastname@example.org. Follow her on Twitter @cconaboy. Liz Kowalczyk can be reached at email@example.com. Todd Wallack can be reached at firstname.lastname@example.org.