Safety Alerts & Recalls

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Roche Announces Recall of ACCU-CHEK FlexLink Plus Infusion Sets
Roche Insulin Delivery Systems is notifying its customers and healthcare professionals about the recall of the ACCU-CHEK FlexLink Plus infusion set, used together with insulin pump systems. The ACCU-CHEK FlexLink Plus infusion set is being recalled because of the potential for under delivery of insulin due to a kinked/bent cannula when inserting the infusion set into the pump. If this remains unnoticed, this can result in under delivery leading to elevation of blood glucose levels, also known as hyperglycemia. The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. If untreated, hyperglycemia could lead to Diabetic Ketoacidosis (DKA), serious illnesses and in severe cases death. This recall only applies to the ACCU-CHEK FlexLink Plus infusion set that was launched in November 2010. The use of the previous version ACCU-CHEK Ultraflex, other ACCU-CHEK infusion sets, insulin pumps, ACCU-CHEK glucose meters, or insulin products are not affected and insulin pump therapy can be continued as directed with these products or other alternatives. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm244487.htm
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Upsher-Smith Expands Recent Recall to Include: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin
Upsher-Smith Laboratories, Inc. is voluntarily expanding its previously announced recall of Jantoven Warfarin Sodium, USP, 3 mg Tablets to include products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating this expanded recall as a precautionary measure because a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher, 10mg strength before it was dispensed. The following products were added to the recall: Amandatine 100 mg Amlodipine 5 mg Androxy 10 mg Baclofen 10 mg Bethanechol 5 mg, 10 mg, and 25 mg Oxybutynin 5 mg The accidental substitution of a different medicine may lead to a change in the effectiveness or possible side effects from the medicines involved. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm244111.htm
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Date Published Title Drug Source
2011-02-24 Roche Announces Recall of ACCU-CHEK FlexLink Plus Infusion Sets Insulin Aspart FDA
2011-02-24 Upsher-Smith Expands Recent Recall to Include: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin Oxybutynin FDA
2011-02-24 Upsher-Smith Expands Recall of Jantoven to Include More Tablet Strengths and Other Products Oxybutynin FDA
2011-02-22 Labeling Change for all Antipsychotic Medications: Warnings Regarding Use During Pregnancy Moban FDA
2011-02-18 Upsher-Smith Announces Nationwide Recall Of Jantoven Warfarin Sodium Tablets, 3mg, Due To Mislabeled Bottles Warfarin FDA
2011-02-18 Terbutaline: Change To the Prescribing Information - Boxed Warning Against Use for Treatment of Preterm Labor Terbutaline FDA
2011-02-17 Janssen Recalls 10 Lots of Invega Sustenna Syringes Paliperidone FDA
2011-02-07 Watson Informs Customers of Important Information About Alcohol Prep Pads in Trelstar Kits Triptorelin FDA
2011-02-07 Qualitest Recalls Hydrocodone Bitartrate And Acetaminophen Tablets Because of Incorrect Package Labeling Hydrocodone with Acetaminophen FDA
2011-02-07 Qualitest Recalls Phenobarbital Tablets Because of Incorrect Package Labeling Phenobarbital FDA
2011-02-04 FDA Update: Avandia, Avandamet and Avandaryl Labels Now Include Information About Heart-Related Risks, Patient Access Restrictions Expected Later This Year Glimepiride and Rosiglitazone FDA
2011-02-03 Lundbeck Inc. No Longer To Make Mebaral FDA
2011-02-01 Novartis Informs Customers of Important Information About Alcohol Prep Pads Packaged With Extavia Interferon beta-1b Kit FDA
2011-01-31 GSK Informs Customers of Important Information About Alcohol Prep Pads in Arixtra Starter Kits Fondaparinux FDA
2011-01-26 Pfizer Informs Customers of Important Information About Alcohol Prep Pads in Relistor Kits Methylnaltrexone FDA
2011-01-21 Bayer Informs Customers of Important Information About Alcohol Prep Pads in Betaseron Kits Interferon Beta-1B FDA
2011-01-18 McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Lots of Rolaids Multi-Symptom Rolaids Multi-Symptom Manufacturer
2011-01-18 McNeil Consumer Healthcare Initiates Voluntary Recall of Certain Over-The-Counter (OTC) Products Acetaminophen with Pseudoephedrine Manufacturer
2011-01-18 Genentech Informs Customers of Important Information About Alcohol Prep Pads in Injectable Medicine Kits Ibandronate Sodium FDA
2011-01-16 The FDA Issues Drug Safety Communication: Update to Ongoing Safety Review of Lantus (Insulin Glargine) and Possible Risk of Cancer Insulin Glargine FDA
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