Safety Alerts & Recalls

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FDA's New Pediatric Prescribing Information Database is a Resource for Parents and Caregivers
Medicines often affect children differently from the way they work in adults. However, the correct and safe dosage for children may not be available because historically not all products are studied in children. To address this situation, Congress recently passed legislation to increase research studies in children and incorporate study results into the medication prescribing information, also known as the medication "labeling" or "package insert". To make it easier for parents and health care professionals to find information about the use of medications in children, the Food and Drug Administration (FDA) has created a database that covers medical products studied in children. Using the following link to the "Pediatric Labeling Information Database," you can search for information by the product’s brand or generic name, or by the condition for which it was studied: The FDA's Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the FDA, the Center for Biologics Evaluation and Research (CBER). The OPT also maintains a Safety Reporting page with information on products that have been tied to safety problems that specifically relate to children: For more information about this alert, please visit:
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Franck’s Pharmacy Recalls All Sterile Human and Veterinary Compounded Prescriptions Distributed Between November 21, 2011 to May 21, 2012
Franck's Pharmacy, located in Ocala, Florida, has announced a product recall involving all Sterile Human and Veterinary Compounded Prescriptions Distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. This recall was issued after the U.S. Food and Drug Administration (FDA) found microorganisms (bacteria) and fungal growth in samples taken from the sterile preparation room at Franck's Pharmacy. Products prepared in a non-sterile environment are more likely to be contaminated and are likely to increase the risk of infection. Sterile products are typically given as injections or infusions and typically are given under the supervision of a doctor or other healthcare provider at the doctor's office, a clinic, or by a nurse in your home. For more information, please visit: and
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Date Published Title Drug Source
2012-05-22 FDA's New Pediatric Prescribing Information Database is a Resource for Parents and Caregivers FDA
2012-05-24 Franck’s Pharmacy Recalls All Sterile Human and Veterinary Compounded Prescriptions Distributed Between November 21, 2011 to May 21, 2012 FDA
2014-05-01 FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips FDA
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Manufacturer
2015-11-12 FDA Completes Review of Blood-Thinning Medicine Plavix (Clopidogrel) Clopidogrel FDA
2016-02-03 Los Profesionales Sanitarios Informados: Viekirax (Ombitasvir, Paritaprevir, Ritonavir) No Recomendado En Pacientes Con Determinados Problemas En El Hígado AEMPS
2016-05-02 FDA Is Reviewing a Study Linking Fluconazole Use and Risk of Miscarriage Fluconazole FDA
2016-05-02 FDA Expands Use of Metformin-Containing Drugs in Certain Patients with Reduced Kidney Function Glipizide with Metformin FDA
2016-06-01 Clinical Trial Results Finds Increased Risk of Leg and Foot Amputations with Use of Canagliflozin (Invokana, Invokamet) Canagliflozin / Metformin FDA
2016-06-01 FDA Advises Avoiding Use of Fluoroquinolone Antibiotics in Certain Uncomplicated Infections Due to Disabling Side Effects That Can Occur Gemifloxacin FDA
2016-06-01 FDA Warns Ketoconazole Should Not Be Prescribed for Skin and Nail Infections Ketoconazole FDA
2016-06-01 FDA warns about rare but serious skin reactions with mental health drug olanzapine Fluoxetine with Olanzapine FDA
2016-07-06 Pfizer Inc Recalls Single Lot of Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle Guaifenesin with Dextromethorphan FDA
2016-07-06 Safecor Health, LLC Recalls Single Lot of Donnatal Elixir Donnatal FDA
2016-07-06 AstraZeneca Pharmaceuticals LP Recalls Select Lots of Tudorza Pressair, 400 mcg per actuation Aclidinium FDA
2016-07-06 Teva Pharmaceuticals USA Recalls Single Lot of Nabumetone 750 mg Tablets Nabumetone FDA
2016-07-06 Teva Pharmaceuticals USA, Inc. a Singlel Lot of Paricalcitol Capsules, 1 mcg Paricalcitol FDA
2016-07-06 Virtus Pharmaceuticals, Llc Recalls Several Lots of Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement Prenatal Vitamins FDA
2017-07-31 Increased Risk of Foot and Leg Amputations with Canagliflozin (Invokana, Invokamet, Invokamet XR) Canagliflozin / Metformin FDA
2017-07-31 FDA Warns about Increased Risk of Serious Pancreatitis with Irritable Bowel Drug Viberzi (eluxadoline) in Patients without a Gallbladder Eluxadoline FDA
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