Safety Alerts & Recalls

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Latest Alerts

FDA Warns About Serious Health Problems Seen in Premature Babies Given Kaletra Oral Solution
The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution. Kaletra oral solution contains the ingredients alcohol and propylene glycol. A safe and effective dose for babies less than 14 days of age (whether born premature or full term) has not been established. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems. The label (prescribing information) for Kaletra oral solution is being revised to include the new warning: The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm246002.htm
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Animas Insulin Pump 2.0 mL Cartridge Recalled
Animas Corporation has sent a letter to its customers to notify them that some of the 2.0 mL insulin cartridges shipped from Animas between Nov. 30, 2010 and Jan. 4, 2011, can leak insulin, resulting in the delivery of less insulin than intended. In addition, if the cartridge has a leak, the pump may not alarm if there is a blockage in the infusion set. The under-delivery of insulin can cause lead to serious complications from high blood sugar and/or diabetic ketoacidosis. The Animas Insulin Pump 2.0 mL Cartridge lot numbers affected by this recall are: B201575 B201576 B201581 B201582 B201583 It is important to note that, this is a contained incident and this issue relates solely to the cartridges contained in the lots listed above. Once the cartridges are replaced, the pump will function as intended. There is not a problem with the pump. Insulin is available in a many different formulations, brands, and packaging. This recall only applies to the 5 specific lot numbers of Animas Insulin Pump 2.0 mL Cartridges listed above. For more information and a list of Frequently Asked Questions about this recall, please visit: https://www.animas.com/urgent-news
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Date Published Title Drug Source
2011-03-08 FDA Warns About Serious Health Problems Seen in Premature Babies Given Kaletra Oral Solution Lopinavir with Ritonavir FDA
2011-03-08 Animas Insulin Pump 2.0 mL Cartridge Recalled Insulin Manufacturer
2011-03-10 New Study: Mothers Taking Opioid Pain Medicines May Place Infants At Increased Risk for Birth Defects MediGuard CRT
2011-03-14 King Pharmaceuticals Inc. Recalls Embeda Morphine and Naltrexone Manufacturer
2011-03-17 Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011 Epinephrine FDA
2011-03-18 Lilly Informs Customers of Important Information About Alcohol Prep Pads in Forteo Starter Kits Teriparatide Manufacturer
2011-03-24 FDA Issues Update for Proton Pump Inhibitors and Risk of Fractures Dexlansoprazole FDA
2011-03-28 Possible Label Switch Prompts Recall of Generic Citalopram 10mg and Finasteride 5mg Citalopram FDA
2011-03-30 FDA Issues Safety Alert: Special Storage and Handling Requirements Must Be Followed for Pradaxa (Dabigatran Etexilate Mesylate) Capsules Dabigatran FDA
2011-03-30 APP Pharmaceuticals, Inc. Recalls Select Lots of Irinotecan Vials Due to Contamination Irinotecan FDA
2011-03-31 McNeil Recalls Single Lot of Tylenol 8 Hour Extended Release Caplet - 150 count Acetaminophen Manufacturer
2011-03-31 McNeil Recalls 10 Lots of OTC Products, Including Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Sinus, Benadryl and Sudafed PE Products Acetaminophen with Pseudoephedrine Manufacturer
2011-04-08 FDA Warns Consumers About Serious Side Effect Linked To the Use of Benzocaine Found in Over-the Counter Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and Other Store Brands FDA
2011-04-14 Ortho-McNeil Voluntarily Recalls Two Lots of Topamax 100 mg Topiramate Manufacturer
2011-04-15 FDA Continues to Receive Reports of Rare Cancer in Patients Treated With TNF Blockers, Azathioprine, and/or Mercaptopurine Etanercept FDA
2011-04-19 FDA Requires Manufacturers to Conduct Safety Studies for Long-Acting Beta-Agonists (LABAs) Mometasone and Formoterol FDA
2011-04-19 Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Can Clog, Block Oral Syringes and Feeding Tubes Lansoprazole FDA
2011-04-20 FDA Announces New Program for Long-Acting and Extended-Release Opioids Methadone FDA
2011-04-25 FDA Issues Update on the Risk Of Progressive Multifocal Leukoencephalopathy With Tysabri Natalizumab FDA
2011-04-25 Clot Risk May Be Higher With Newer Birth Control Pills Drospirenone with Ethinyl Estradiol MediGuard CRT