Safety Alerts & Recalls

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Recombinant Human Growth Hormone (Somatropin): FDA Conducting Ongoing Safety Review
The U.S. Food and Drug Administration (FDA) is informing the public that results from a study conducted in France found that persons with certain kinds of short stature treated with recombinant human growth hormone (somatropin) during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. This study, the Sante Adulte GH Enfant (SAGhE) study, involved patients who had idiopathic growth hormone deficiency and idiopathic or gestational short stature. The FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review. Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm237773.htm
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Recall - Mislabeled Unit Dose Vials Albuterol Sulfate Inhalation Solution 0.083%, 3 mL
The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. Only the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The correct concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons. There is concern that using the mislabeled albuterol nebulizer solutions could lead to an accidental albuterol overdose. Significant overdosing of a patient could lead to signs and symptoms of albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats/minute. The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60 are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol formulations or products are included in this recall. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238624.htm
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Date Published Title Drug Source
2010-12-24 Recombinant Human Growth Hormone (Somatropin): FDA Conducting Ongoing Safety Review Somatropin FDA
2011-01-03 Recall - Mislabeled Unit Dose Vials Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Albuterol FDA
2011-01-06 Teva Recalls Single Lot of Metronidazole 250 mg Tablets Metronidazole Manufacturer
2011-01-10 Teva Pharmaceuticals Inc. Recalls Several Lots of ProAir HFA Albuterol FDA
2011-01-10 Sandoz Inc. Recalls Single Lot of Carvedilol Tablets Carvedilol FDA
2011-01-10 Sandoz Inc. Recalls Several Lots of Lorazepam Tablets Lorazepam FDA
2011-01-11 Novo Nordisk, Inc. A Recalls Single Lot of GlucaGen Hypokit Emergency Kit Glucagon FDA
2011-01-11 Reports of Accidental Overdose With Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) Morphine FDA
2011-01-13 The FDA Takes New Steps Aimed at Cutting Risks of Severe Liver Injury from Acetaminophen Pentazocine Hydrochloride with APAP FDA
2011-01-15 Bristol-Myers Squibb Recalls Additional Avalide Tablets Hydrochlorothiazide with Irbesartan Manufacturer
2011-01-16 The FDA Warns About Possible Risk of Severe Liver Injury with Dronedarone (Multaq) Dronedarone 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
2011-01-18 Genentech Informs Customers of Important Information About Alcohol Prep Pads in Injectable Medicine Kits Ibandronate Sodium FDA
2011-01-18 McNeil Consumer Healthcare Initiates Voluntary Recall of Certain Over-The-Counter (OTC) Products Acetaminophen with Pseudoephedrine Manufacturer
2011-01-18 McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Lots of Rolaids Multi-Symptom Rolaids Multi-Symptom Manufacturer
2011-01-21 Bayer Informs Customers of Important Information About Alcohol Prep Pads in Betaseron Kits Interferon Beta-1B FDA
2011-01-26 Pfizer Informs Customers of Important Information About Alcohol Prep Pads in Relistor Kits Methylnaltrexone FDA
2011-01-31 GSK Informs Customers of Important Information About Alcohol Prep Pads in Arixtra Starter Kits Fondaparinux FDA
2011-02-01 Novartis Informs Customers of Important Information About Alcohol Prep Pads Packaged With Extavia Interferon beta-1b Kit FDA
2011-02-03 Lundbeck Inc. No Longer To Make Mebaral FDA