This recall was initiated after the firm was notified that Food and drug Administration (FDA) investigators observed methods used by Front Range Labs to assess sterility and other qualities (e.g., strength and stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on these lots. FDA has concerns that test results obtained from Front Range Labs may not be reliable.
If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening. Wellness Pharmacy has yet to receive any reports of adverse events related to this recall.
Recalled medications were distributed to individual patients and physician offices nationwide. The liquid medications are in either clear or amber sterile vials ranging in size from 1ml to 50ml. They can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.
Wellness Pharmacy is notifying customers by phone and regular mail. Patients and physicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy.
http://www.consumeraffairs.com/recalls/wellness-pharmacy-recalls-sterile-products-082713.html
No comments:
Post a Comment