Drug Recalls or Withdrawals

• Date Released: 11/7/2008
  Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON^® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

  Anyone with questions regarding the recall of Mylicon^® Gas Relief Dye Free Drops should call 1-800-222-9435.

  For additional information: www.fda.gov/oc/po/firmrecalls/johnsonjohnson11_08.html

• Date Released: 11/7/2008
  ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of 5 generic products with multiple strengths. These lots have been recalled due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosages of these drugs.

  The medications include: Propafenone 150mg, 225mg, and 300mg tablets, Isosorbide Mononitrate Extended Release 30mg and 60mg tablets, Morphine Sulfate Extended Release 15mg tablets, Morphine Sulfate Immediate Release 15mg and 30mg tablets, and Dextroamphetamine Sulfate 10mg tablets.

  Anyone with questions regarding this voluntary recall of the above listed medications made by ETHEX Corporation should call 1-800-748-1472.

  For additional information: www.fda.gov/oc/po/firmrecalls/ethex11_08.html

• Date Released: 11/5/2008
  Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

  These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

  Anyone with questions regarding this recall of ReliOn 1cc, 31 gauge Syringes labeled as 100units for use with U-100 Insulin should call 1-866-780-5436

  For additional information: www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

• Date Released: 10/15/08
  ETHEX Corporation announced today that is has voluntarily recalled three specific lots of Dextroamphetamine Sulfate 5mg tablets due to the possible presence of oversized tablets. Oversized tablets may contain twice the labeled amount of the active ingredient. The recalled lots, 77946, 81141, 81142, were distributed between January 2007 and May 2008.

  No report of any oversized Dextroamphetamine Sulfate tablets has been received. If someone were to take a higher than expected dose of Dextroamphetamine Sulfate, possible adverse effects may include tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, and dry mouth. ETHEX Corporation is issuing this precautionary voluntary recall due to a small number of oversized tablets in lots which had not yet been distributed.

  Anyone with questions regarding this voluntary recall of dextroamphetamine sulfate tablets made by ETHEX Corporation should call 1-800-321-1705.

  Additional information regarding this recall can be found at: http://www.fda.gov/oc/po/firmrecalls/ethex10_08.html

• Date Released: 7/14/08
  Roxane Laboratories, Inc announced today that is has voluntarily recalled two lots of sodium polystyrene sulfonate suspension, USP 15g/60mL. Roxane Laboratories, Inc. found a sample of the product tested positive for a strain of yeast. Yeast could potentially affect immunocompromised patients through a wide range of symptoms including thrush, skin rash, and sepsis. Currently there have been no complaints or adverse events reported for the affected lots.

  Anyone with questions regarding this voluntary recall of sodium polystyrene sulfonate suspension USP, 15g/60mL made by Roxane Laboratories, Inc should call 1-800-962-8364.

  Additional information regarding this recall can be found at: http://www.fda.gov/oc/po/firmrecalls/roxane07_08.html

• Date Released: 6/13/08
  ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008.

  No report of unexpected side effects or injury has been received. However, opioids such as morphine, have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure, apnea, and hypotension.

  The voluntary recall follows a report that a tablet with as much as double the appropriate thickness was identified in a previously recalled lot. No oversized tablets have been identified in any additional distributed lot of these products and, based on our investigation, there are likely to be few, if any, oversized tablets in the recalled lots. The decision to recall the additional lots listed above has been taken as a responsible precaution because of the possibility that there may be oversized tablets in those lots.

  Anyone with questions regarding this voluntary recall of morphine sulfate 30mg and 60mg extended release tablets made by ETHEX Corporation should call 1-800-321-1705.

  For additional information: www.fda.gov/oc/po/firmrecalls/ethex206_08.html
  
  
  ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60mg Extended Release Tablets

• Date Released: 6/9/08
  ETHEX Corporation has voluntarily recalled a single lot of morphine sulfate 60mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. The lot was distributed by ETHEX Corporation between April 16th and April 27th of 2008.

  This lot recall is due to the possibility that there may be other similar oversized tablets that may have been commercially released in the affected lot. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. No report of unexpected side effects or injury has been received. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression and low blood pressure.

  Anyone with questions regarding this voluntary recall of morphine sulfate 60mg extended release tablets made by ETHEX Corporation should call 1-800-321-1705.

  For additional information: www.fda.gov/oc/po/firmrecalls/ethex06_08.html

• Date Released: 5/30/08
  King Pharmaceuticals^®, Inc. has decided to discontinue the manufacturing of Intal^® Nebulizer Solution. Intal^® Nebulizer Solution is a prophylactic agent indicated in the management of patients with bronchial asthma. Supplies still exist at pharmacies and wholesalers so the exact date of product unavailability is not known.

  Anyone with questions regarding the discontinuation of Intal^® Nebulizer Solution manufactured by King Pharmaceuticals^®, Inc. should call 1-800-776-3637.

  For additional information: www.fda.gov/cder/drug/shortages/IntalDHCP_2008.pdf

• Date Released: 5/16/08
  Medicis has received a report that one bottle of the antibiotic Solodyn extended release tablets 90mg in a 30 count bottle contains Azasan (azathioprine) 75mg instead of Solodyn. Azasan is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for treatment of rheumatoid arthritis.

  Taking Azasan instead of Soloddyn presents a health hazard and safety risk to patients. Side effects associated with the use of AZASAN^®, particularly in the elderly, include mylosuppression (decrease in the number of red and white blood cells and platelets), infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects.

  Any inquiries related to this recall should be addressed to Stericycle Customer Service at 1-888-656-6381

  For additional information: www.fda.gov/oc/po/firmrecalls/medicis05_08.html

• Date Released: 4/30/08
  King Pharmaceuticals^®, Inc. has decided to discontinue the manufacturing and distribution of TILADE^® Inhaler. TILADE^® is indicated for maintenance therapy in the management of adult and pediatric patients 6 years of age and older with mild to moderate asthma. TILADE^® will remain available through pharmacies and wholesalers until current supplies are exhausted. This discontinuation is not due to any safety or efficacy concerns.

  Anyone with questions regarding the discontinuation of production and distribution of TILADE^® manufactured by King Pharmaceuticals, Inc. should call 1-800-776-3637.

  For additional information: www.fda.gov/cder/drug/shortages/Tilade_DHCPApril2008.pdf

• Date Released: 4/28/08
  The FDA reported that Actavis Totowa LLC is initiating a Class I nationwide recall of Digitek^® (digoxin tablets, USP, all strengths) for oral use. Digitek^® is used to treat heart failure and abnormal heart rhythms. 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 is appropriate.

  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.

  Anyone with questions regarding the voluntary recall of Digitek^® oral tablets, manufactured by Actavis Totowa LLC, should call 1-888-276-6166.

  For additional information: www.fda.gov/oc/po/firmrecalls/actavis04_08.html

• Date Released: 3/28/08
  Covidien, formally Tyco Healthcare, will be recalling 32 lots of Heparin Sodium pre-filled syringes that were manufactured and distributed by Covidien in the United States. This product recall was initiated due to the notification received from the supplier, Scientific Protein Laboratories LLC (SPL), disclosing that two lots of Heparin Sodium acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue.

  The FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

  Anyone with questions regarding the voluntary recall of Covidien Heparin Sodium should call 1-800-346-7197, ext 8677.

  For additional information: www.fda.gov/oc/po/firmrecalls/covidien03_08.html

• Date Released: 3/21/2008
  Schwarz Pharma, a company of the UCB group, will be recalling Neupro (rotigotine) transdermal patches at the end of April 2008. This action is due to the formation of rotigotine crystals in the patches. When the drug crystallizes, a decreased amount of drug is available to be absorbed through the skin. Therefore, the efficacy of the affected product may vary.

  The product will not be available in the United States after the end of April 2008. However, patients must first be gradually down-titrated with the current supplies available. It is strongly advised that patients do not abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises. It is advised that physicians begin down-titrating all patients currently using Neupro as per the guidelines in the product label.

  Anyone with questions regarding the recall of Neupro should call 1-800-477-7877.

  For additional information: www.neupro.com/pdf/Neupro_US_Physicians.pdf

• Date Released: 3/20/2008
  American Health Packaging (AHP), a subsidiary of AmerisourceBergen Corporation, today announced a voluntary recall of 1,421 units (25 vials per unit) of 10000 USP units/ml heparin sodium injection 1ml vials as part of the broader February 29, 2008 recall of Heparin products made by Baxter Healthcare Corporation. The vials were manufactured by Baxter and then placed by AHP into individually labeled bags for use in pharmacy automation equipment.

  As with the Baxter recall, this recall is due to the higher than usual number of reports of adverse patient reactions involving the product. Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock.

  Anyone with questions regarding AHP heparin sodium vial products should call 1-800-707-4621.

  For additional information: www.fda.gov/oc/po/firmrecalls/americanhealth03_08.html

• Date Released: 3/1/2008
  Actavis South Atlantic, LLC, formally Abrika Pharmaceuticals Inc., in cooperation with the U.S. Food and Drug Administration (FDA) announced a nationwide voluntary recall of specific lots of fentanyl 25mcg/hr, 50mcg/hr, 75mcg/hr, and 100mcg/hr with expiration dates of May 2009 through December 2009. This action is due to a possible defect that can cause the patches to leak the potent opioid, fentanyl gel, into the packaging of the patch. As a result, patients or caregivers may then be directly exposed to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which can be fatal.

  Anyone with Actavis Fentanyl transdermal system patches with the specific listed lot numbers should call 1-877-422-7452.

  For additional information, including the specific lot numbers affected: http://www.fda.gov/oc/po/firmrecalls/actavis03_08.html

• Date Released: 2/28/2008
  Baxter International Inc. announced the company will be voluntarily recalling all of the remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparine flush products. The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month. Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock.

  The FDA has concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can recall its remaining heparin sodium injection and heparin flush products. This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

  Anyone with Baxter heparin sodium vial products should call 1-800-422-9837.

  For additional information: http://www.fda.gov/oc/po/firmrecalls/baxter02_08.html

• Date Released: 2/17/2008
  Actavis South Atlantic, LLC, formally Abrika Pharmaceuticals Inc., in cooperation with the U.S. Food and Drug Administration (FDA) announced a nationwide recall of specific lots of fentanyl 25mcg/hr, 50mcg/hr, 75mcg/hr, and 100mcg/hr with expiration dates of May through August 2009. This action is due to a possible defect that can cause the patches to leak the potent opioid, fentanyl gel, into the packaging of the patch. As a result, patients or caregivers may then be directly exposed to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which can be fatal.

  Anyone with Actavis Fentanyl transdermal system patches with the specific listed lot numbers should call 1-877-422-7452.

  For additional information, including the specific lot numbers affected: http://www.fda.gov/oc/po/firmrecalls/actavis02_08.html

• Date Released: 2/12/2008
  PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in cooperation with the U.S. Food and Drug Administration (FDA) announced a nationwide voluntary recall of all lots of Duragesic 25mcg/hr CII pain patches and fentanyl 25mcg/hr patches sold by Sandoz Inc. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara.

  The patches being recalled may have a cut along one side of the drug reservoir within the patch, causing the release of fentanyl gel into the packaging. As a result, patients or caregivers may then be directly exposed to fentanyl gel. The direct exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which can be fatal. Patches with a cut edge that have leaked gel will not provide effective pain relief and should be disposed of by flushing them down the toilet, using caution not to handle them directly.

  Anyone with 25 mcg/hr Duragesic patches being recalled should call 800-547-6446.

  Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236.

  For additional information: http://www.fda.gov/oc/po/firmrecalls/pricara02_08.html

• Date Released: 1/25/2008
  The U.S. Food and Drug Administration (FDA) announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two identified lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

  The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes. Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.

  For additional information: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01785.html

• Date Released: 1/23/2008
  Bayer and the FDA have withdrawan Leukine solution for injection from the market for safety reasons. Bayer noticed an increase in spontaneous reports of adverse events including syncope and hypotension after Leukine solution for injection was reformulated to include edetate disodium (EDTA). Bayer is currently working to reformulate Leukine solution for injection; however, no release date has been announced.

  Lyophilized Leukine has not been associated with any increase in adverse event reports and will remain available through a limited access program.

  For additional information: http://www.fda.gov/medwatch/safety/2008/Leukine_DHCP_01-23-2008.pdf

• Date Released: 3/30/2007
  Novartis followed the FDA's advisory to voluntary discontinue the marketing of Zelnorm based on the recent findings of an increased risk of serious cardiovascular adverse events associated with the use of the drug.
  
  Zelnorm was approved for the short-term treatment of women with constipation predominate irritable bowel syndrome and for the treatment of chronic constipation in men and women under the age of 65.
  
  Physicians who prescribed Zelnorm for Gateway Health Plan members should work with these patients and transition them to other therapies appropriate to their symptoms and needs.
  
  For additional information: http://www.fda.gov/cder/drug/advisory/tegaserod.htm
• Availability of Zelnorm under Restricted Access
  • Date Released: 7/27/2007
  This program, called a "treatment IND," allows restricted access to Zelnorm if there is no comparable alternative drug or therapy available to treat the disease in the intended patient population. The program allows patients to make an informed decision to take the medication when the benefits outweigh the risks associated with the drug. Please see the below additional information link for inclusion and exclusion criteria for restricted access of Zelnorm.
  
  For additional information: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01673.html

• Date Released: 3/29/2007
  The FDA announced that manufacturers of pergolide will voluntarily remove these drugs from the market because of the risk of serious damage to patients' heart valves. Pergolide is a dopamine agonist taken to manage the tremors and other symptoms of Parkinson's disease.
  
  Treatment with pergolide should not be stopped abruptly because rapid discontinuation of any dopamine agonists can be dangerous. There are alternative therapies available for Parkinson's disease, including three other dopamine agonists that have not been associated with valvular heart disease. In addition, there are published transition regimens that describe the conversion from one dopamine agonist to another.
  
  Therefore, the removal of pergolide products from the market is not expected to adversely affect patient care because of the alternative therapies available.
  
  For additional information: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html