Ameridose, a major supplier of sterile injectable medications to hospital pharmacies across the United States, is voluntarily recalling all of its unexpired products after an inspection by federal drug regulators raised concerns about potential contamination of the company’s products, the Food and Drug Administration said in a release.
Most products distributed by Ameridose such as antibiotics, anesthetics and tranquilizers are represented as sterile products. The use of non-sterile injectable medications represents a serious threat to patient health and can cause life-threatening infections.
Patients have a right to expect the medications they receive, including steroid injections to relieve pain, are safe and effective when used as directed. Drug manufacturers have a legal responsibility to ensure that sterile medications are produced in sanitary conditions and are free of contamination.
The FDA and the state of Massachusetts launched an inspection of the Ameridose facility in Westborough, Mass., as part of the agency’s response to the ongoing nationwide fungal meningitis outbreak. Ameridose is a company that shares common management by the same parties as New England Compounding Center, the compounding pharmacy responsible for the drugs linked to the fungal meningitis outbreak. The FDA’s preliminary inspection raised questions about a lack of sterility assurance for medications produced at or distributed by the facility.
The recall of Ameridose products is not based on reports of patients with infections caused by Ameridose products at this time, the FDA said. But the FDA did notify doctors and hospitals to stop using all Ameridose products. The FDA notified Ameridose that it will seek improvements in the company’s sterility testing process.
Ameridose has entered into a voluntary agreement to cease all pharmacy and manufacturing operations.
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