Lowlite Investments Inc, doing business as Olympia Pharmacyin Orlando, Florida, has initiated a voluntary recall of all unexpired sterile drug products compounded by the pharmacy because of a lack of sterility assurance.
"The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility," the company says in a press release posted May 29 on the FDAWeb site.
The affected product was compounded between December 17, 2012, and March 27, 2013. The recall includes all sterile products that Lowlite supplied to patients and offices of licensed medical professionals with a use-by date of September 25, 2013, or earlier.
A complete list of the recalled products, lot numbers and expiration dates can be found on the FDA Web site.
The recall is being conducted as a "precautionary measure," the company says. To date, they have not received any reports of injury or illness associated with the recalled product. However, "in the event a sterile product is compromised patients are at risk for serious and possible life threatening infections."
Lowlite is notifying customers by telephone, fax, or mail to return the products to the pharmacy.
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