Regulatory Focus™ > News Articles > Compounding Pharmacy Recalls Continue as FDA Inspection Finds Still More Deficiencies

Compounding Pharmacy Recalls Continue as FDA Inspection Finds Still More Deficiencies

Posted 26 March 2013 | By Alexander Gaffney, RAC 

A steady drumbeat of recalls from compounding pharmacies has struck a note for the third time in approximately a week, with Massachusetts-based Pallimed Compounding Pharmacy issuing a notice indicating that all sterile products manufactured at the facility should be recalled and not used after an inspection by the US Food and Drug Administration (FDA) indicated deficiencies.

In a statement, the company said it had not been made aware that any compounded product made by it has been associated with any injuries or illnesses, but was instead acting out of an "abundance of caution." The recall does not extend to the company's non-sterile products.

Though the recall is technically a voluntary one under FDA's terminology because it was not ordered by the agency, Pallimed said the Massachusetts Board of Registration in Pharmacy has since issued a "limited Cease and Desist Order" preventing it from compounding sterile products.

"By undertaking this recall action, Pallimed can move forward to ensure that our products will always meet the highest standards of safety and customer expectations," the company added.

An article in the Boston Globe reported that Pallimed had in December 2012 been ordered to stop compounding sildenafil citrate, otherwise known as Viagra, because it was being made with "improper components."

Third Recall in a Week

The recall, which affects 16 supposedly sterile products, is at least the third in the time span of one week.

A 17 March 2013 recall notice by New Jersey-based Med Prep Consulting recalled 83 of its products after they were found to be contaminated with visible particulate matter, later confirmed by FDA investigators to be mold. Just days later, on 20 March 2013, Georgia-based Clinical Specialties issued its own voluntary recall of more than 60 of its products, citing similar sterility assurance concerns.

The recalls come just as FDA Commissioner Margaret Hamburg has called for additional authority to regulate the industry, saying her agency lacks the statutory authority and resources it needs to effectively oversee the burgeoning industry. In a blog posting on 22 March 2013, Hamburg also floated the idea of subjecting the compounding industry to user fees, which could require companies to pay facilities registration fees and product compounding fees in order to pay for FDA inspections.

The steady pace of high-profile recall notices could be seen as providing Hamburg with justification for her requests, but might also attract some negative attention. A letter from Sen. Richard Blumenthal (D-CT) last week to Hamburg seemed incredulous at the fact that the agency had not shut down Med Prep Consulting despite multiple disciplinary actions taken against the company in the last decade, and that the problems leading to the recall were detected by a vigilant nurse-not FDA regulators.

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