Safety Alerts & Recalls

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Vintage Pharmaceuticals Recalls Select Lots of Q-Tussin DM and Iophen DM-NR Liquid
Vintage Pharmaceuticals, LLC has recalled select lots of Q-Tussin DM and Iophen DM-NR liquid, containing Dextromethorphan, 10 mg per 5 mL and Guaifenesin, 100 mg per 5 mLliquid. The following lot numbers are being recalled because routine testing found that the product in this lot may contain impurities: Q-Tussin DM liquid, 16 fl oz (473 mL) bottle - lot numbers L145C10A and L028C10A Iophen DM-NR liquid, 16 fl oz (473 mL) bottle lot numbers L099D10A, L107C10A, and L115C10A Q-Tussin DM liquid and Iophen DM-NR liquid contain the active ingredients dextromethorphan and guaifenesin and are commonly used in the treatment of cough and chest congestion. The combination of dextromethorphan and guaifenesin is also sold under other brand names. This recall alert only applies to the select lots of Q-Tussin DM and Iophen DM-NR liquid. No other dextromethorphan and guaifenesin products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm265709.htm
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FDA Report Cites Customer Complaints of Shrink Wrap Found in Vaccine Vials
According to the US Food and Drug Administration (FDA), charred bits of plastic shrink wrap have been found in vials of Merck & Co. vaccines, including Gardasil for the prevention of HPV infection, Varivax for chicken pox, Pneumovax for pneumococcal disease, Zostavax for shingles and MMR II for measles, mumps and rubella. The agency believes the contamination took place because shrink wrap used to protect vials had not been completely removed ahead of the vaccine filling process. Receiving a vaccine with plastic shrink wrap may raise the risk of an injection site reactions such as redness, swelling, or itching. However, Merck said it does not believe there have been any adverse events associated with the plastic contamination problem and they are working to resolve the problem. For more information, please visit: http://blogs.wsj.com/health/2011/07/29/charred-shrink-wrap-in-merck-vaccines-read-the-fda-inspection-reports/
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Date Published Title Drug Source
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of Q-Tussin DM and Iophen DM-NR Liquid Guaifenesin with Dextromethorphan FDA
2011-08-02 FDA Report Cites Customer Complaints of Shrink Wrap Found in Vaccine Vials Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18) Vac FDA
2011-08-01 McNeil Lowers Maximum Tylenol Dose to Prevent Overdoses Acetaminophen Manufacturer
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Linezolid (Zyvox) Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Linezolid FDA
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Methylene Blue Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Methylene Blue FDA
2011-07-22 Reducing Fever and Relieving Pain in Children: Safe Use of Acetaminophen Acetaminophen FDA
2011-07-22 FDA Reviewing Results of Study Multaq (Dronedarone) in Patients with Permanent Atrial Fibrillation Dronedarone FDA
2011-07-22 FDA Reviewing of Oral Bisphosphonates and Potential Increased Risk of Esophageal Cancer Ibandronate Sodium FDA
2011-07-21 Non-Safety-Related Recall of Several Lots of Daytrana Patches Methylphenidate Manufacturer
2011-07-19 D.S.C. Laboratories Recalls Single Lot of Anecream Lidocaine 4% Cream Lidocaine FDA
2011-07-19 Teva Recalls Several Lots of Prazosin Capsules, 1 mg Prazosin FDA
2011-07-19 King Pharmaceuticals Recalls Single Lot of Cortisporin Otic Solution Otosporin FDA
2011-07-19 Bayer Health Recalls Single Lot of Genuine Bayer Aspirin Aspirin FDA
2011-07-19 Teva Recalls Several Lots of Hydralazine Tablets, 10 mg, 25 mg, 50 mg and 100 mg Hydralazine FDA
2011-07-19 Pfizer Recalls Select Lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg Nitroglycerin FDA
2011-07-19 Drug Interaction Warnings Added to Prescribing Information for Seroquel Quetiapine FDA
2011-07-13 CDC Revises Recommendations for the Use of Birth Control Methods During the Initial Period After Childbirth MediGuard CRT
2011-07-12 Fetal Exposure To Valproate Medicine During Pregnancy May Cause Cognitive Delay Divalproex Sodium FDA
2011-07-07 Chantix: New Study Links Drug to Heart Problems Varenicline MediGuard CRT
2011-06-30 New Study Suggests High-Dose Statins May Cause Diabetes Simvastatin MediGuard CRT