An unannounced inspection at a Massachusetts compounding pharmacy recently uncovered suspicious material on medication containers, leading the operation to order a voluntarily recall for all its 2013 products.
Pallimed Soluitions, Inc. of Woburn issued the recall after the visit from the Food and Drug Administration (FDA) and the Massachusetts Board of Registration in Pharmacy. The agencies found an unknown substance on sterile compounding products. Five affected vials were discovered and no illness has been reported. The recalled drugs include those used for erectile dysfunction treatment, testosterone replacement therapy, vitamin injections and ophthalmic preparations.
The Board of Registration has ordered the pharmacy to halt sterile compounding activities. In December, the compounding pharmacy was among three cited by the state pharmacy board during unannounced inspections. Pallimed was ordered to stop production of sildenafil citrate, which is sold as Viagra. The inspection found the medication was being prepared with improper components.
Medication involved in the recall was shipped to patients and medical offices in Massachusetts, New Hampshire, Rhode Island, Maine, Connecticut, Vermont and 15 other states. Recipients are advised to discontinue use of medications and return to Pallimed Solutions.
The FDA and Massachusetts Board of Registration in Pharmacy share regulation of compounding pharmacies in Massachusetts, which in contrast to large manufacturers, are allowed to dispense medications for individuals with prescriptions, often with conditions which cannot be met in regular pharmacies.
Both agencies are still responding to the aftermath of 2012, when the New England Compounding Center in Framingham was linked to a deadly fungal meningitis outbreak, which sickened over 650 people in 19 states and killed at least 39 others.
In January, Gov. Deval Patrick proposed new licensing requirements for compounding pharmacies, including to let the state assess fines for violating regulations, to protect whistleblowers and reorganize the state pharmacy board.
Along with federal regulations, compounding pharmacies in Massachusetts operate under 247 CMR. Under M.G.L. 94C, section 21 and 105 CMR 721.000, pharmacies and pharmacists must have a prescription for a specific patient before they dispense a medication.