Drug Recalls or Withdrawals

• Date Received: 10/28/09
  Qualitest Pharmaceuticals is voluntarily recalling all lots of Accusure Insulin Syringes. These syringes may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, pushed back into the syringe, or remain in the skin after injection.

  Anyone with questions regarding this nationwide recall of Qualitest Pharmaceuticals Accusure Insulin Syringes may call 1-800-444-4011.

• Date Received: 8/14/09
  Barr Laboratories, Inc is voluntarily recalling lot number 311756 of generic Adderall 20mg tablet in the 100 count bottles due to some tablet exceeding weight requirements which may lead to more potent tablets. Potential adverse reactions to supratherapeutic doses include palpitations, tachycardia, hypertension, headache, tremor, dizziness, blurred vision, sweating, agitation, and decreased appetite.

  Anyone with questions regarding this lot drug recall of Barr Laboratories, Inc generic Adderall 20mg tablet may call 1-888-742-5578.

• Date Received: 8/4/09
  NovoNordisk, Inc is discontinuing Novolin InnoLet disposable insulin pens and Novolin PenFill 3mL cartridges. The final date of sale of the following products is December 31, 2009. These products include Regular, NPH, and 70%NPH and 30% Regular Insulin.

  Anyone with questions regarding the discontinuation of the Novolin InnoLet and PenFill Products should call: 1-800-727-6500.

• Date Received: 7/31/09
  King Pharmaceuticals, Inc. will soon discontinue the manufacturing of Intal Inhaler. King Pharmacueticals, Inc. will continue to accept orders until current inventories are exhausted. This action is not the result of any safety or efficacy issues. Because of the planned phase out of the Intal Inhaler, please refrain from initiating treatment with the product.

  Anyone with questions regarding the discontinuation of the Intal Inhalers should call 1-800-776-3637.

• Date Received: 7/14/2009
  Brookstone Pharmaceuticals, LLC, has initiated a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (80mg/0.8mL) in 16 ounce (473 ml) bulk containers. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations (160mg/5mL).This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing.

  Anyone with questions regarding the recall of Brookstone Pharmaceuticals, LLC Concentrated Acetaminophen Drops should call 1-800-541-4802, option 2.

  Additional information regarding this recall can be found at: www.fda.gov/Safety/Recalls/ucm171780.htm

• Date Received: 5/12/2009
  A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

  Anyone with questions regarding the recall of A S Medication Solutions, LLC packaged Digoxin 0.25mg should call 847-680-3515.

  Additional information regarding this recall can be found at: www.fda.gov/Safety/Recalls/ArchiveRecalls/ucm150734.htm

• Date Received: 4/8/2009
  Genentech, Inc. has announced a phased voluntary withdrawal of the psoriasis medication Raptiva from the United States market. Since September 2008, Genentech has received 3 reports of progressive multifocal leukoencephalopathy (PML). PML is a rapidly progressive infection of the central nervous system caused by the JC virus that leads to death or severe disability.

  Raptiva will no longer be available after Monday, June 8, 2009. The intent of the phased withdrawal is to provide sufficient time for prescribers to identify their patients on Raptiva, inform them that they need to discontinue treatment and plan a careful transition to alternative psoriasis therapies as appropriate.

  Anyone with questions regarding the withdrawal of Raptiva from the market should call 1-888-835-2555.

  Additional information regarding this recall can be found at: www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM149681.pdf

• Date Received: 3/31/2009
  Caraco Pharmaceutical Laboratories, Ltd. announced all tablets of Caraco brand Digoxin (0.125mg and 0.25mg) are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin.

  Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

  Anyone with questions regarding the recall of Caraco brand Digoxin should call 1-800-818-4555.

  Additional information regarding this recall can be found at: www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm128443.htm

• Date Received: 3/25/2009
  Watson Pharmaceuticals, Inc announced on March 23, 2009 a voluntary lot recall of propafenone HCl 225mg tablets (lot number 112680A). The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. Propafenone is used to treat cardiac arrhythmias. It has a narrow therapeutic index, so some patients who are particularly sensitive to small variantions in dose may experience potentially serious side effects, include arrhythmias or low blood pressure.

  Anyone with questions regarding this recall of propafenone HCl 225mg made by Watson Pharmaceuticals, Inc should call 1-888-352-9616.

  Additional information regarding this recall can be found at: www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm129032.htm

• Date Received: 1/28/2009
  ETHEX Corporation announced on January 28, 2009 a nationwide voluntary recall of two products at the retail pharmacy level. These products include hydromorphone 2mg, 4mg, 8mg tablets and metoprolol succinate ER 25mg, 50mg, 100mg and 200mg tablets. This is a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some specific products made by ETHEX have been recalled in the past due to oversized tablets. These products are being removed to assure there are no other defective products in the market.

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

  Additional information regarding this recall can be found at: www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm128537.htm