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Recall issued on U.S. Compounding sterile products


 

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U.S. Compounding Inc. is issuing a recall on all sterile products distributed between March 14, 2015, and Sept. 9, 2015, according to a safety alert from the Food and Drug Administration.

The product recall applies to all aseptically compounded and packaged USC sterile products distributed to hospitals, patients, providers, and clinics because of FDA concerns over lack of sterility assurance. Because of the risk to any patients using a compromised product, USC is proceeding voluntarily with the recall.

Patients or providers who received sterile compounded products from USC within the recall date and have not expired should stop using the products immediately, quarantine the product until proper disposal is possible, and contact USC as soon as possible to coordinate a plan to return the product.

Patients should also contact their physicians if they have experienced any issues relating to the recalled product, and physicians should contact patients to inform them of the recall and to advise them to stop using the product.

The USC recall does not apply to any nonsterile compounded medication produced or distributed by USC, according to the FDA alert.

Find the full safety alert on the FDA website.

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