Another US-based pharmaceutical compounding pharmacy has recalled all of its products after it said they could potentially be contaminated with mold.
A similar recall was initiated in 2012 by the New England Compounding Pharmacy (NECC), whose products have been linked to a massive outbreak of fungal meningitis that has killed dozens and made ill hundreds of other patients. When FDA investigators raided the plant in October 2012, they found vials of product at the facility visibly contaminated with black mold, to say nothing of a long list of other deficiencies.
In the wake of those findings and patient deaths, regulators have started to take a much more active role in going after compounding pharmacies that are alleged to be deficient in their manufacturing practices.
In their most basic form, compounding pharmacies fill an important role. If a doctor needs a specialized form of a drug made for a patient, he or she can order it to be made from a compounding pharmacy. Those pharmacies largely get around FDA regulations-or did in the past, anyway-by compounding products for a specific patient and on a one-off basis.
The problem, as regulators have begun to find out, is that many of these compounding pharmacies exhibit two problems: Many compound products in bulk (as opposed to on a per-prescription basis) and do not adhere to good manufacturing practices such as keeping the compounding areas sterile.
Since raiding NECC, FDA has sent at least 15 Form 483 warning letters to compounding entities for alleged deficiencies found at various manufacturing facilities.
That list could soon add one more company, with Medprep Consulting Inc. announcing the recall of all of its products after it was notified by a Connecticut hospital that at least five of its 50 ml bags of its intravenous fluids (magnesium sulfate 2GM in dextrose) were contaminated with visible particulate matter.
"In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance," the company said in a statement. While the company said no injuries or illnesses had yet been brought to its attention, its response would seem to indicate that compounding pharmacies are operating their vigilance operations much more vigorously after the NECC fiasco.
The products-83 in all-include a huge range of product types, including sterile injectables and pre-filled syringes, bags, pumps and vials. All were distributed directly to regional hospital pharmacies in the New Jersey, Pennsylvania, Connecticut and Delaware regions, the company said.