Infection Reports Lead Georgia Compounder to Recall All Sterile Items
This week has not been kind to compounding pharmacies, nor has the past year. A 2012 mold contamination hazard tied to products from a Massachusetts facility led to a widespread outbreak across the country, leading regulators to reconsider the way that such operations are regulated. And this week, a New Jersey compounder had to recall all products because of concerns over sterility being compromised.
Now, another compounder has made the move to recall all sterile products because of similar sterility concerns. The Augusta, Georgia-based Clinical Specialties Compounding Pharmacy announced the recall, which comes on the heels of the Food and Drug Administration finding that the compounding site may be susceptible to issues that could compromise sterility.
These findings were made known after five reports of severe eye infections were made in conjunction with Avastin that had been repackaged by the compounder. Once the CDC found out about these endophthalmitis infections, which could lead to lifelong vision loss, they related their findings to the FDA. What’s more, the Avastin that led to the infections was not even approved for the usage which it was administered for.
State health officials are working with the CDC and FDA to determine how serious the contamination threat is. In the meantime, healthcare professionals are being asked to check their inventory for Clinical Specialties compounded items and refrain from giving such items to patients. Adversity related to any of the products should be reported to MedWatch.