Note: US Recall News has received numerous comments involving serious injury and even death from consumers who claim to have been taking this drug at the time. Please click here to read more about the Digoxin / Digitek recall, including comments by other readers.
CONTACT: STERICYCLE CUSTOMER SERVICE 1-888-276-6166
FOR IMMEDIATE RELEASE — MORRISTOWN, NJ — APRIL 25, 2008 — ACTAVIS TOTOWA LLC, A UNITED STATES MANUFACTURING DIVISION OF THE INTERNATIONAL GENERIC PHARMACEUTICAL COMPANY ACTAVIS GROUP, IS INITIATING A CLASS I NATIONWIDE RECALL OF DIGITEK® (DIGOXIN TABLETS, USP, ALL STRENGTHS) FOR ORAL USE. THE PRODUCTS ARE DISTRIBUTED BY MYLAN PHARMACEUTICALS INC., UNDER A “BERTEK” LABEL AND BY UDL LABORATORIES, INC. UNDER A “UDL” LABEL.
THE VOLUNTARY ALL LOT RECALL IS DUE TO THE POSSIBILITY THAT TABLETS WITH DOUBLE THE APPROPRIATE THICKNESS MAY HAVE BEEN COMMERCIALLY RELEASED. THESE TABLETS MAY CONTAIN TWICE THE APPROVED LEVEL OF ACTIVE INGREDIENT THAN IT APPROPRIATE.
DIGITEK® IS USED TO TREAT HEART FAILURE AND ABNORMAL HEART RHYTHMS. THE EXISTENCE OF DOUBLE STRENGTH TABLETS POSES A RISK OF DIGITALIS TOXICITY IN PATIENTS WITH RENAL FAILURE. DIGITALIS TOXICITY CAN CAUSE NAUSEA, VOMITING, DIZZINESS, LOW BLOOD PRESSURE, CARDIAC INSTABILITY AND BRADYCARDIA. DEATH CAN ALSO RESULT FROM EXCESSIVE DIGITALIS INTAKE. SEVERAL REPORTS OF ILLNESSES AND INJURIES HAVE BEEN RECEIVED.
ACTAVIS MANUFACTURES THE PRODUCTS FOR MYLAN AND THE PRODUCTS ARE DISTRIBUTED BY MYLAN AND UDL UNDER THE BERTEK AND UDL LABELS. BERTEK AND UDL ARE AFFILIATES OF MYLAN.
ANY CUSTOMER INQUIRIES RELATED TO THIS ACTION SHOULD BE ADDRESSED TO STERICYCLE CUSTOMER SERVICE AT 1-888-276-6166 WITH REPRESENTATIVES AVAILABLE MONDAY THROUGH FRIDAY, 8 AM TO 5 PM EST. ADDITIONAL INFORMATION ABOUT THE VOLUNTARY RECALL CAN ALSO BE FOUND AT WWW.ACTAVIS.US.
RETAILERS WHO HAVE THIS PRODUCT ARE URGED TO RETURN THE PRODUCT TO THEIR PLACE OF PURCHASE. IF CONSUMERS HAVE MEDICAL QUESTIONS, THEY SHOULD CONTACT THEIR HEALTH CARE PROVIDERS.
THIS RECALL IS BEING CONDUCTED WITH THE KNOWLEDGE OF THE FOOD AND DRUG ADMINISTRATION.
ANY ADVERSE REACTIONS EXPERIENCED WITH THE USE OF THIS PRODUCT, AND/OR QUALITY PROBLEMS SHOULD ALSO BE REPORTED TO THE FDA’S MEDWATCH PROGRAM BY PHONE AT 1-800-FDA-1088, BY FAX AT 1-800-FDA-0178, BY MAIL AT MEDWATCH, FDA, 5600 FISHERS LANE, ROCKVILLE, MD 20852-9787, OR ON THE MEDWATCH WEBSITE AT WWW.FDA.GOV/MEDWATCH.
Beryl M. Jones says
My wife ran out of her prescription of Digoxin ( Bertek ) on May 10, 2008. She called Walgreen to order a refill and the pharmacy told her they could not refill it because of a recall. She called her physician and he said “baloney”, thats not so. He then called Walgreen and instructed them to refill it, which they did. I went online and saw where it indeed has been recalled. However, Walgreen used
a form of Digoxin ( Lannett ) for the refill. Her physician absolutely ignored her
after giving him a copy of the recall notice, never bothering to explain anything. I think he was miffed that we might explore this question ourselves. When we got the mail this date there was a “URGENT DRUG RECALL INFORMATION ” letter in the mailbox from Walgreen. Neither the pharmacist or the doctor apparently have no interest in making an attempt to clarify or explain the difference.
My question, what in the world is going on ???? One thing certain, we must have
the wrong family doctor as well as the wrong pharmacy.