September 08, 2014
FDA MedWatch - Pharmacy Creations Certain Products: Recall – Potential Non-Sterility 09/06/2014
AUDIENCE: Pharmacy, Patients
ISSUE: Pharmacy Creations has voluntarily recalled four product lots (see firm Press Release) following testing results conducted that indicated that the product lots may have the potential of not being sterile. 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. To date there have been NO reported adverse events associated with the use of the product.
BACKGROUND: The prescription preparations were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014 and June 18, 2014 and were mailed directly to patients and physicians.
RECOMMENDATION: Customers should return the recalled product lots. Physicians and patients that have products which are being recalled should stop use and return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form
or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the complete MedWatch Safety summary including a link to the firm Press Release at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm413053.htm