Sandoz is recalling 10 lots of its generic oral contraceptive Introvale in the US, because of a packaging flaw.
The possibility that the packaging flaw will cause serious adverse health consequences are remote, and there are no reports to date of any adverse event. The recall is being made as a precautionary measure to minimize any potential of patients being impacted.
The lots were distributed only in the United States and were distributed between January 2011 and May 2012.
The FDA is warning consumers and health care professionals that a counterfeit version of Adderall is being purchased on the internet. Adderall, approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance. Preliminary laboratory tests revealed that the counterfeit Adderall, 30-milligram tablets, contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.
The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Authentic Adderall 30 mg tablets produced by Teva are round orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet.
A New Jersey judge in the Aredia/Zometa state court cases found that a Zometa plaintiff’s lawsuit had been dismissed, applying Virginia’s statute of limitations.
The case’s facts are, like many others in the Aredia/Zometa cases, sad. Plaintiff, a Virginia resident, developed osteonecrosis of the jaw after allegedly receiving infusions of Zometa.
Everyone agreed that Virginia’s substantive law applied. The court found that, if the substantive law of Virginia governs plaintiff’s damage claims, the defendant may assert applicable affirmative defenses under Virginia law.
Last month brought changes to forty-three (43) medical product labels (slightly up from 39 changes in March), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.
For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary, which will identify the safety labeling section, the revised subsection, and a brief summary of the new or modified safety information.
The following medications have been affected:
Last month brought changes to thirty-nine (39) medical product labels (way down from 65 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.
For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary which will identify the safety labeling section, the revised subsection, and a brief summary of the new or modified safety information.
The following medications have been affected:
The FDA has announced that there is a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab) that has been obtained by some medical practices. Lab tests have confirmed that the Altuzan, an injectable cancer medication, contains no active ingredient. Altuzan, the brand name for Avastin in Turkey.
The FDA first warned in February that a counterfeit supply of the widely used Avastin had turned up in the U.S. The Wall Street Journal has traced that supply through a network of firms in Canada, Barbados, the United Kingdom, Denmark, Switzerland, Egypt, and Turkey.
Read more: http://www.foxnews.com/health/2012/04/04/fda-finds-new-batch-counterfeit-avastin/#ixzz1r527ZHxg
Last month brought changes to sixty-five (65) medical product labels (up from 63 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.
For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will view the detailed summary which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.
The following medications have been affected:
Last month brought changes to sixty-three (63) medical product labels (up from 40 changes in December), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.
For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will view the detailed summary which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.
The following medications have been affected:
Drug Recall Lawyer Blog