Recalls of aseptic products due to sterility concerns produced by compounding pharmacies in Georgia and New Jersey represent the latest in a string of quality problems found at compounders across the country.
Clinical Specialties of Martinez, Ga., is recalling all of its sterile products, including 40 lots of Avastin distributed to doctors’ offices in Georgia, Louisiana, South Carolina and Indiana since Dec. 18 after receiving reports of serious eye infections from physicians who used the drug off-label to treat macular degeneration in elderly patients.
Tinton Falls, New Jersey-based Med Prep Consulting has recalled all of its products after reports of visible mold in five bags of magnesium sulfate products.
Contamination products during repackaging of Genentech’s Avastin into syringes for use in ophthalmic procedures have also been prominent at Massachusetts-based New England Compounding Center (NECC) and Infupharma, in Florida (IPQ “Special Report” on the Crisis in Pharmacy Compounding, pp. 23-24). In Infupharma’s case, at least 12 people were reported to have suffered vision loss or permanent blindness from the contaminated product.
Avastin – approved for the treatment of certain types of colon, rectal and lung cancer – is not approved specifically for the treatment of eye disease. However, it is used off-label by many doctors to treat macular degeneration. It can be purchased at about $50 per dose from compounding pharmacies as compared to about $2,000 per dose for Lucentis – another Genentech drug that has the same mode of action and is approved as an eye treatment.
Both Infupharma and NECC were using vials of the product from Genentech over a period of days or weeks following their initial puncture and repackaging the contents into single-use syringes. Each received a warning letter in which FDA pointed out that “the manufacturer’s package insert for Avastin states: ‘discard any unused portion left in a vial, as the product contains no preservatives.’” The NECC warning letter was issued in 2006. Infupharma received a warning in 2012.
Med Prep Consulting agreed to close under a voluntary consent order with New Jersey until at least April 5 while state authorities continue to investigate the root cause of its magnesium IV contamination, according to the state’s Board of Pharmacy.
The initial recall was expanded to include all products due to “preliminary findings of practices at the site which raise concerns about a lack of sterility assurance,” according to an FDA statement.
Also regarding Med Prep, New Jersey Health Commissioner Mary O’Dowd said in a statement that “this investigation is evolving. At this time, in an abundance of caution, the Department of Health recommends that any health care facility that has received products from Med Prep should inventory them and remove them from use.”
There have been no reports of illness in any patient who received the drugs.
See related stories:
FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders
Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage
Debate Continues Among Stakeholders on Framework for Regulating Pharmacy Compounding; Legislative Options Reviewed at FDLI Forum
Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown
Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States
Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps
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IPQ’s Special Report on the Crisis in Pharmacy Compounding and its Implications