FDA Announces Recall of All Non-Expired Drugs Sterile Manufactured by Unique Pharmaceuticals

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Sterile-Unique -Pharmaceutical-Drugs-RecalledThe U.S. Food and Drug Administration (FDA) just announced that it is alerting health care professionals and consumers about a recall of all non-expired drug products purported for sterile use that are sold and distributed by Unique Pharmaceuticals Ltd., which is based in Temple, Texas.

The recalled products include Lot Number 86513, N-Acetyl Cysteine 20 percent, as well as all of the firm’s other non-expired, purportedly sterile drug products.

The FDA is advising health care professionals to immediately check their medical supplies and quarantine all Unique Pharmaceuticals’ sterile drug products. The recalled drugs are not to be administered to patients as they may be contaminated. Administration of a non-sterile drug product that is meant to be sterile may lead to serious and potentially life-threatening infections or death.

Unique Pharmaceuticals distributed the recalled products nationwide. Most product labels include the following: Unique Pharmaceuticals, Temple TX USA 76502.

The agency indicated that two recent inspections at Unique Pharmaceuticals’ facility that it conducted revealed insanitary conditions. Insanitary conditions lead to a lack of sterility assurance of drug products that are produced at that facility. Inspections also revealed sterility failures in numerous lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.

On July 11, 2014, the FDA issued a formal request to Unique Pharmaceuticals advising the drug maker to issue a recall of all of its non-expired, ostensibly sterile drug products. The agency also requested Unique Pharmaceuticals stop its sterile compounding operations. Unique Pharmaceuticals agreed to the FDA’s request for a recall and is stopping its sterile compounding operations until sufficient corrections are made at its facility.

“Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge health care professionals to follow recall instructions issued by the firm.”

The FDA indicated that it is not aware of any reports of illness tied to use of Unique Pharmaceutical products, to date. Patients who have received any drug product produced by Unique Pharmaceuticals and who are concerned should contact their health care professional, wrote the FDA.

Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on November 27, 2013, added section 503B to the FDCA. Under this section, a compounder may elect to become an outsourcing facility. Outsourcing facilities must comply with current good manufacturing practice requirements; will be subject to inspection by the FDA, according to a risk-based schedule; and must meet certain other requirements, including reporting adverse events and providing the FDA with certain information about the products compounded.