A New Jersey-based compounding pharmacy has voluntarily recalled 4 prescription preparations distributed in 4 states due to potential contamination, according to the FDA.
Pharmacy Creations first announced the recall on September 6, 2014, following test results that indicated 4 of its drug product lots “may have the potential of not being sterile,” the company warned in a press release.
“Although we cannot be certain that the product subject to the recall is contaminated, to the extent it was, there are serious health implications for the use of contaminated product in all patients which could include development of a life-threatening infection,” the company stated. “We are voluntarily recalling the products as a precautionary measure, out of an abundance of caution and in order to ensure the public health and the safety of our patients.”
According to Pharmacy Creations, the recalled lots of ascorbic acid, glutathione, magnesium chloride, and tropi/cyclo/phenyl/tobra/flurb were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014, and June 18, 2014, via direct mail to patients and physicians.
The compounding pharmacy has notified all parties affected by the voluntary recall and arranged for the return of the potentially contaminated product lots.
Although no adverse events have been associated with the use of the 4 drug products to date, Pharmacy Creations has advised affected patients to report related adverse reactions or quality problems to their health care providers and the FDA’s MedWatch program.