The sister company of the Massachusetts pharmacy linked to a deadly outbreak of fungal meningitis is voluntarily recalling all of its drug products, including many pain medications . The recall was announced after the Food and Drug Administration raised concerns about a “lack of sterility assurance” at the Ameridose facility in Westborough, Massachusetts.
(UPDATE: A complete list of the drugs being recalled can be found here: Ameridose Voluntary Product Recall List.
The FDA advised health care providers to stop using Ameridose products and said it would work with other drug makers to increase production of medications in short supply.
Ameridose is the sister company of the New England Compounding Center (NECC), which produced and distributed a contaminated steroid blamed for the deaths of 29 patients. The steroid, primarily used in epidural injections for back pain, has been linked to 377 infections around the country. All but nine have resulted in meningitis.
Last week the FDA released an inspection report saying it has found numerous instances of bacteria and mold growing at the New England Compounding Center. The FDA is currently inspecting Ameridose’s facility.
“Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries,” the FDA said in a statement that also noted there have been no reports of infections linked to Ameridose products.
The recall includes many widely used pain relievers, such as lidocaine, fentanyl, morphine and hydromorphone. The recall announcement covers all Ameridose products made since April that haven’t passed their expiration date. The company supplies drugs to thousands of hospitals and health care providers around the country.
“Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products. Nevertheless, out of an abundance of caution, we are undertaking this recall,” Ameridose said in a statement on its website.
Ameridose makes over two thousand types of drugs and medical solutions, and some are already in short supply. The FDA said it would work with other manufacturers to increase production of those drugs.
“The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies,” said FDA Commissioner Margaret Hamburg.