FDA Initiates Second Compounding Pharmacy Recall This Week
Clinical Specialties Compounding Pharmacy's ophthalmic products at issue
Published: March 21, 2013
For the second time this week, a compounding pharmacy has been forced to expand a recall from one product to all compounded products it produces.
On March 18, Clinical Specialties Compounding Pharmacy, in Augusta, Ga., recalled all lots of its Avastin unit dose syringes after reports of 5 intraocular infections from physician's offices. Today, the recall was expanded to include all sterile products produced by the compounding pharmacy, including cataract drops, cyclosporine 1% ophthalmic drops, laser ophthalmic drops, a number of mitomycin solutions, ophthalmic dilation gel and a number of vancomycin solutions.
The products covered under the recall were distributed nationwide between October 19 and March 19. The expanded recall "is conducted in follow-up to concerns regarding practices at the site [that] cannot [en]sure the sterility of the products," says a company press release. The FDA recommends that healthcare providers stop using all sterile products distributed by Clinical Specialties Compounding.
"Although there has been no evidence of contamination with sterile products other than the specified Avastin lots, Clinical Specialties has decided in the interest of their patients to proceed with this recall process," says the company.
As we reported earlier, a New Jersey compounding pharmacy last weekend issued a voluntary nationwide recall of all lots of all products compounded at its facility due to potential mold contamination. In that case, a nurse at Yale-New Haven Hospital in Connecticut is being credited with spotting floating mold in vital intravenous drugs, prompting the mass recall.
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